FDA Adverse Event
Injury
Summary report: N
UV-ABSORBING COLLAMER FOLDABLE INTRAOCULAR LENS
MDR report key: 578260
·
Received March 3, 2005
Report
- Report Number
- 2023826-2005-00290
- Event Type
- Injury
- Date Received
- March 3, 2005
- Date of Event
- January 24, 2005
- Report Date
- February 3, 2005
- Manufacturer
- STAAR SURGICAL CO.
- Product Code
- HQL
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
THE SURGEON IMPLANTED A CC4204BF COLLAMER PLATE LENS BUT IT SPLIT WHILE BEING INSERTED. THE INCISION WAS ENLARGED TO REMOVE THE LENS AND SUTURES WERE NOT REQUIRED. AN MSI-PF INJECTOR AND AN SFC-25 FP CARTRIDGE WERE USED BUT THE LOT NUMBERS WERE NOT KNOWN BY THE FACILITY.
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 | Required Intervention |