FDA Adverse Event
Other
Summary report: N
COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA
MDR report key: 1616835
·
Received February 11, 2010
Report
- Report Number
- 2023826-2010-00138
- Event Type
- Other
- Date Received
- February 11, 2010
- Date of Event
- January 14, 2010
- Report Date
- January 15, 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
- TN, US
- Reporter Occupation
- PHYSICIAN ASSISTANT
Narratives
Additional Manufacturer Narrative · 1
(B) (4). (B) (4).
Description of Event or Problem · 1
THE REPORTER STATED THE SURGEON INSERTED A CQ2015 COLLAMER THREE PIECE LENS. LENS TORE WHILE BEING INJECTED INTO THE PT'S EYE. THE LENS WAS REMOVED WITH NO PT INJURY. THE SURGEON USED AN OFF-LABEL INJECTION SYSTEM.
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. | CQ2015 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | INJECTOR: MODEL - NA AND LOT NUMBER - NA| CARTRIDGE: MODEL - NA AND LOT NUMBER - NA |