FDA Device recall Z-2411-2023
Alcon Custom Pak
- FDA Device
- Class II
- ongoing
- Published 2023-08-23
On 2023-08-23 the FDA classified a Class II recall of Alcon Custom Pak by Alcon Research, citing reports of patient injury during use in procedures due to potential for plastic debris from over-tightening with included plastic wrench.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2411-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-06-28 |
| Published | 2023-08-23 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Alcon Research |
| Distribution | US |
Product
Alcon Custom Pak
Reason
Reports of patient injury during use in procedures due to potential for plastic debris from over-tightening with included plastic wrench.
Identifiers
| code_info | Catalog No. Catalog #, 0007-67, 0091-69, 0210-70, 0302-82, 0349-78, 0365-75, 0437-38, 0680-74, 0693-66, 0781-63, 0815-6…Catalog No. Catalog #, 0007-67, 0091-69, 0210-70, 0302-82, 0349-78, 0365-75, 0437-38, 0680-74, 0693-66, 0781-63, 0815-68, 0880-41, 0888-69, 0900-28, 0938-60, 0956-69, 0995-82, 10008-16, 10014-63, 10014-64, 10019-15, 10027-12, 10066-19, 10101-16, 10101-17, 10101-18, 10101-20, 10166-16, 10214-17, 10214-19, 10222-21, 10222-22, 10223-16, 10223-17, 10223-18, 10264-15, 10275-17, 10308-11, 10342-17, 10356-15, 10421-28, 10477-20, 10482-15, 10557-11, 10557-12, 10558-11, 10558-12, 10568-13, 10572-19, 10575-17, 10594-14, 10632-20, 10638-27, 10731-20, 10735-21, 10772-34, 10782-28, 10804-17, 10825-17, 10835-20, 1084-67, 10868-18, 10872-14, 10875-22, 1087-67, 1087-69, 10881-19, 10911-12, 10999-16, 11022-08, 11052-13, 11106-12, 11124-19, 11147-18, 11162-38, 11162-39, 1119-82, 11211-25, 11212-18, 11212-19, 11225-12, 11225-13, 11230-25, 11230-26, 11254-32, 11254-33, 11288-16, 11328-16, 11367-20, 11367-21, 11367-23, 11371-20, 11401-13, 11413-12, 11413-14, 11416-12, 11421-11, 11426-24, 11444-27, 11466-21 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2411-2023%22
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