FDA Adverse Event
Injury
Summary report: N
UV-ABSORBING COLLAMER FOLDABLE INTRAOCULAR LENS
MDR report key: 582502
·
Received March 17, 2005
Report
- Report Number
- 2023826-2005-00347
- Event Type
- Injury
- Date Received
- March 17, 2005
- Report Date
- February 15, 2005
- Manufacturer
- STAAR SURGICAL CO.
- Product Code
- HQL
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
THE SURGEON IMPLANTED A CC4204BF COLLAMER PLATE LENS AND THEN EXPLANTED IT. THE FACILITY WAS UNABLE TO PROVIDE ANY INFO AS TO WHY THE LENS WAS REMOVED OR IF THERE WAS ANY PT INJURY OR PRODUCT MALFUNCTION. AN MSI-PF INJECTOR AND AN SFC-25 FP CARTRIDGE WERE USED BU THE FACILITY WAS UNABLE TO PROVIDE THE LOT NUMBERS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UV-ABSORBING COLLAMER FOLDABLE INTRAOCULAR LENS | INTRAOCULAR LENS | HQL | STAAR SURGICAL CO. | CC4204BF | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |