FDA Device recall Z-1328-2021
Alcon Custom Ophthalmic Surgical Procedure Packs
- FDA Device
- Class II
- terminated
- Published 2021-04-07
On 2021-04-07 the FDA classified a Class II recall of Alcon Custom Ophthalmic Surgical Procedure Packs by Alcon Research, citing reports have been received concerning mold found on gowns included in custom ophthalmic surgery packages.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1328-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-02-02 |
| Published | 2021-04-07 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Alcon Research |
| Distribution | US |
Product
Alcon Custom Ophthalmic Surgical Procedure Packs
Reason
Reports have been received concerning mold found on gowns included in custom ophthalmic surgery packages.
Identifiers
| code_info | Lot Number Pak Number 2461031H 0012-61, 2461032H 0017-68, 2471522H 0017-69, 2470351H 0091-68, 2475039H 0091-69, 2…Lot Number Pak Number 2461031H 0012-61, 2461032H 0017-68, 2471522H 0017-69, 2470351H 0091-68, 2475039H 0091-69, 2477748H 0147-62, 2462158H 0148-63, 2460228H 0188-76, 2467978H 0204-58, 2462215H 0234-66, 2467189H 0234-66, 2469722H 0234-66, 2469576H 0235-74, 2471338H 0235-74, 2476349H 0235-74, 2456156H 0316-66, 2451430H 0365-74, 2464636H 0437-38, 2466614H 0437-38, 2469145H 0437-38, 2475934H 0437-38, 2478372H 0437-38, 2465722H 0472-56, 2451167H 0486-69, 2457152H 0486-69, 2468378H 0540-73, 2477328H 0540-74, 2457720H 0557-75, 2459855H 0557-75, 2465117H 0557-75, 2467632H 0557-75, 2471693H 0557-75, 2450010H 0562-64, 2452620H 0562-64, 2465723H 0562-64, 2472329H 0562-64, 2448882H 0587-88, 2449035H 0587-88, 2450960H 0587-88, 2470118H 0587-88, 2465724H 0607-57, 2470245H 0613-80, 2475040H 0613-80, 2459856H 0630-68, 2465118H 0630-68, 2471694H 0630-68, 2474352H 0630-68, 2476843H 0630-68, 2458037H 0633-57, 2463374H 0633-57, 2457722H 0650-75, 2465119H |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1328-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.