FDA Adverse Event
Other
Summary report: N
COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA
MDR report key: 1200171
·
Received October 1, 2008
Report
- Report Number
- 2023826-2008-01234
- Event Type
- Other
- Date Received
- October 1, 2008
- Date of Event
- September 2, 2008
- Report Date
- September 4, 2008
- Manufacturer
- STAAR SURGICAL CO.
- Product Code
- HQL
- PMA / PMN Number
- P990013
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
EVALUATION RESULTS - OTHER: VISUAL INSPECTION OF THE RETURNED PRODUCT SHOWED THAT ONE HAPTIC WAS TORN AND THE OTHER WAS TORN COMPLETELY OFF AND BENT. THERE WAS A CLEAR SURGICAL RESIDUE ON THE LENS.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE SURGEON INSERTED A CQ2015A THREE PIECE COLLAMER LENS AND THE LENS TORE UPON INSERTION. THE LENS WAS REMOVED WITHOUT ANY PATIENT INJURY. THE CUSTOMER USED AMO INJECTOR WHICH IS OFF LABEL USE.
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 | 86 YR | INJECTOR: MODEL UNKNOWN| CARTRIDGE: MODEL CQ CARTRIDGE-FP| STAARVISC II |