FDA Adverse Event
Injury
Summary report: N
CT LUCIA 602
MDR report key: 17635228
·
Received August 25, 2023
Report
- Report Number
- MW5145006
- Event Type
- Injury
- Date Received
- August 25, 2023
- Date of Event
- August 21, 2023
- Report Date
- August 23, 2023
- Manufacturer
- CARL ZEISS MEDITEC PRODUCTION, LLC.
- Product Code
- HQL
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- TX, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
ON POD 1 FOLLOWING CATARACT SURGERY, THE SURGERY NOTED THE LENS HAD FLIPPED VERTICALLY REQUIRING ADDITIONAL SURGERY TO REPLACE THE IOL. CARL ZEISS IOL CT LUCIA 602. DIOPTER 21.5, SN: (B)(6), EXP: 2026-07-31.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1000124 | CT LUCIA 602 | INTRAOCULAR LENS | HQL | CARL ZEISS MEDITEC PRODUCTION, LLC. | 3S2109500618 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |