The Alcon Custom Pak
Medical device recall Z-1702-2015. Published in FDA’s Enforcement Report on Jun 10, 2015.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Jun 10, 2015. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 219,680 units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
The supplier of the Devon Light Glove, a component of the Alcon Custom PAK, recalled the gloves due to the potential for splits and holes on the glove. Should the user be unaware that the Light Glove is torn/split, surgical site infections are possible.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
The Alcon Custom Pak. The Alcon Customer Pak is an assemblage of single-use medical devices and accessories designed by medical professionals for specific ophthalmic surgical procedures. Some Paks contain the Devon Light Glove.
219,680 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
1367627H 1367700H 1370468H 1374839H 1377749H 1378861H 1381718H 1381790H 1384702H 1386455H 1387943H 1388009H 1388010H 1388166V 1388511H 1388512H 1388513H 1389356H 1389471H 1389472H 1390944H 1391983H 1393363H 1393364H 1393610H 1396053H…
Every code shown here, 1,998 characters
1367627H 1367700H 1370468H 1374839H 1377749H 1378861H 1381718H 1381790H 1384702H 1386455H 1387943H 1388009H 1388010H 1388166V 1388511H 1388512H 1388513H 1389356H 1389471H 1389472H 1390944H 1391983H 1393363H 1393364H 1393610H 1396053H 1399825H 1401814H 1402528V 1403164H 1403821H 1405058H 1408045H 1409183H 1409851H 1415212H 1419278H 1419338H 1421822H 1425061H 1425803H 1428919H 1430191H 1430728H 1430754H 1430755H 1431698H 1433391H 1434865H 1434953H 1435810H 1441247H 1444893H 1445803V 1446438H 1446497H 1447083H 1447480H 1449115V 1451237H 1451787H 1456506H 1456809H 1457967H 1460058H 1463012H 1463152H 1463308H 1463395H 1464333H 1464505H 1464902H 1466086H 1466240H 1466495H 1466496H 1469343H 1469571H 1470568V 1470948H 1472070H 1475160H 1475161H 1475597H 1476584H 1477332H 1477581H 1477752H 1477789H 1480137H 1480257H 1480467H 1481877H 1483926H 1485422H 1485722H 1486478H 1487040H 1488898H 1490193H 1491469H 1494604H 1494975H 1497536H 1497607H 1498335H 1498787H 1499119V 1499177V 1499713H 1500764H 1500937H 1501079H 1501126H 1501347H 1501960H 1503259H 1503266H 1503483H 1504431H 1507406H 1507738H 1508991H 1509297H 1509499H 1509675H 1509769H 1510006H 1510111H 1510287H 1510377H 1510398H 1510883H 1510972H 1511703H 1512533H 1512784H 1514974H 1515044H 1515191H 1515282H 1515340H 1515361H 1515378H 1515928H 1515936H 1515975H 1517329H 1517760H 1517976H 1518049H 1518179H 1518269H 1518484H 1520563H 1522791H 1523155H 1523160H 1523173H 1523316H 1523331H 1523336H 1523768H 1524215H 1524448H 1525744H 1526126H 1526641H 1526674H 1526676H 1526747H 1528758H 1528880H 1528917H 1529328H 1529531H 1529544H 1529568H 1529853H 1529992H 1530097H 1530518V 1532033H 1532240H 1532511H 1532539H 1532545H 1532609H 1532711H 1533114V 1534334H 1534494H 1534524H 1535116H 1535151H 1535357H 1535394H 1535409H 1535663H 1537187H 1537240H 1538233H 1539697H 1540681H 1540814H 1541683H 1542552H 1542946H 1543648H 1547698H 1548509H 1550073H 1553312H 1553317H 1553815H 1553906H 1554405H 1554413H 1555652H 1556724H 1557109H 1557989H…
FDA’s list runs to 6,713 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide Distribution - US Nationwide and the countries of Australia and Canada.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Apr 28, 2015.
- FDA classified it on Jun 2, 2015.
- FDA’s Enforcement Report published it on Jun 10, 2015.
- FDA terminated it on Mar 24, 2016.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Alcon Research, Ltd., of Fort Worth, TX.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 6,713 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.