FDA Adverse Event
Other
Summary report: N
COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA
MDR report key: 1638963
·
Received March 19, 2010
Report
- Report Number
- 2023826-2010-00273
- Event Type
- Other
- Date Received
- March 19, 2010
- Date of Event
- March 1, 2010
- Report Date
- March 2, 2010
- Manufacturer
- STAAR SURGICAL CO.
- Product Code
- HQL
- PMA / PMN Number
- P990013
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4). (B)(4).
Description of Event or Problem · 1
THE REPORTER STATED A CQ2015A COLLAMER ASPHERIC THREE PIECE LENS WAS DAMAGED DURING THE LOADING PROCESS, THE HAPTIC WAS BENT WHILE BEING PUSHED THROUGH THE INJECTOR. THERE WAS PT CONTACT BUT NO INJURY. THE LENS WAS CUT TO REMOVE FROM THE EYE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA | INTRAOCULAR LENS | HQL | STAAR SURGICAL CO. | CQ2015A | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | CARTRIDGE MODEL CQ CARTRIDGE-FP -LOT # UNK| INJECTOR MODEL MSI-PM -LOT # UNK |