FDA Adverse Event
Other
Summary report: N
SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL
MDR report key: 1644860
·
Received March 25, 2010
Report
- Report Number
- 2023826-2010-00296
- Event Type
- Other
- Date Received
- March 25, 2010
- Date of Event
- March 4, 2010
- Report Date
- March 4, 2010
- Manufacturer
- STAAR SURGICAL CO.
- Product Code
- HQL
- PMA / PMN Number
- P880091
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). (B)(4).
Description of Event or Problem · 1
THE REPORTER STATED THE SURGEON WAS INSERTING AN AA4203TL TORIC SILICONE SINGLE PIECE LENS AND HE NOTED THE HAPTIC HAD SHEARED OFF IN THE CARTRIDGE. THERE WAS PT CONTACT BUT NO INJURY. ANOTHER SAME MODEL LENS WAS IMPLANTED. THE REPORTER STATED THE CAUSE OF THE DAMAGED LENS WAS DUE TO A LOADING ERROR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL | INTRAOCULAR LENS | HQL | STAAR SURGICAL CO. | AA4203TL | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | INJECTOR: MODEL MSI-TR - LOT NUMBER UNK| CARTRIDGE: MODEL MTC-60 FP - LOT NUMBER 1239210 |