FDA Adverse Event
Malfunction
Summary report: N
COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA
MDR report key: 1870334
·
Received October 5, 2010
Report
- Report Number
- 2023826-2010-01015
- Event Type
- Malfunction
- Date Received
- October 5, 2010
- Date of Event
- September 21, 2010
- Report Date
- September 24, 2010
- Manufacturer
- STAAR SURGICAL CO.
- Product Code
- HQL
- PMA / PMN Number
- P900048
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE REPORTER STATED, THE SURGEON INSERTED AN AQ2015A SILICONE ASPHERIC THREE PIECE LENS AND THE HAPTIC BROKE. THE LENS WAS REMOVED WITH NO PATIENT INJURY. ANOTHER 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. | AQ2015A | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | CARTRIDGE: MODEL #UNK, LOT #UNK| INJECTOR: MODEL #UNK, LOT #UNK |