{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-04-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "status": "Terminated", "city": "Fort Worth", "state": "TX", "country": "United States", "classification": "Class II", "openfda": {}, "product_type": "Devices", "event_id": "71156", "recalling_firm": "Alcon Research, Ltd.", "address_1": "6201 South Fwy", "address_2": "N/A", "postal_code": "76134-2099", "voluntary_mandated": "Voluntary: Firm initiated", "initial_firm_notification": "Letter", "distribution_pattern": "Worldwide Distribution - US Nationwide and the countries of Australia and Canada.", "recall_number": "Z-1702-2015", "product_description": "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.", "product_quantity": "219,680 units", "reason_for_recall": "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.", "recall_initiation_date": "20150428", "center_classification_date": "20150602", "termination_date": "20160324", "report_date": "20150610", "code_info": "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 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