FDA Adverse Event
Injury
Summary report: N
COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA
MDR report key: 1585667
·
Received January 21, 2010
Report
- Report Number
- 2023826-2010-00066
- Event Type
- Injury
- Date Received
- January 21, 2010
- Date of Event
- December 22, 2009
- Report Date
- December 23, 2009
- Manufacturer
- STAAR SURGICAL CO.
- Product Code
- HQL
- PMA / PMN Number
- P990013
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
NO LENS IN RETURNED PACKAGING. CONCLUSIONS: THE PRODUCT FOR THIS COMPLAINT WAS NOT RETURNED FOR EVALUATION. WITHOUT THE RETURNED PRODUCT, THE COMPLAINT CANNOT BE CONFIRMED. BASED ON THE COMPLAINT HISTORY, A SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED.
Description of Event or Problem · 1
THE REPORTER STATED THE SURGEON INSERTED A CQ2015A COLLAMER ASPHERIC THREE PIECE LENS. THE LENS WAS TORN DURING INSERTION INTO THE EYE. THE LENS WAS REMOVED WITH THE INCISION ENLARGED AND SUTURES WERE REQUIRED. THE REPORTER DID NOT PROVIDE LOT NUMBER FOR THE INJECTOR. THERE WERE THREE LENSES USED ON THIS PATIENT. SEE MFR# 223826-2010-00065 AND 2023826-2010-00067 FOR THE OTHER TWO LENSES. A FOURTH LENS WAS IMPLANTED.
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 | UNK | Required Intervention | INJECTOR: MODEL - EPIPHANY, LOT # UNK |