FDA Adverse Event
Other
Summary report: N
COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL
MDR report key: 1422953
·
Received July 23, 2009
Report
- Report Number
- 2023826-2009-00805
- Event Type
- Other
- Date Received
- July 23, 2009
- Date of Event
- June 23, 2009
- Report Date
- June 24, 2009
- Manufacturer
- STAAR SURGICAL COMPANY
- Product Code
- HQL
- PMA / PMN Number
- P990013
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
EVAL: RESULTS - A VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND ONE HAPTIC AND PIECE OF OPTIC IS TORN OFF AND MISSING. THERE WAS EVIDENCE OF CLEAR SURGICAL RESIDUE.
Description of Event or Problem · 1
THE REPORTER STATED THE SURGEON INSERTED AND REMOVED A CC4204BF COLLAMER PLATE LENS. LENS WAS DAMAGED UPON INSERTION DUE TO LOADING ERROR. NO ENLARGED INCISION OR SUTURES REQUIRED. NO PT INJURY. THERE WERE THREE ATTEMPTS TO IMPLANT A LENS. THE FIRST TWO ATTEMPTS THE LENS WAS DAMAGED DUE TO LOADING ERRORS. ON THE THIRD ATTEMPT THE EYE CAPSULE WAS TOO WEAK TO HOLD LENS. ON THE FOURTH ATTEMPT A SULCUS LENS WAS IMPLANTED, NOT A STAAR LENS. SEE MFR REPORT# 2023826-2009-00804 AND 2023826-2009-00805.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL | INTRAOCULAR LENS | HQL | STAAR SURGICAL COMPANY | CC4204BF | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | INJECTOR: MODEL INDIGO-P| FORM TIP PLUNGER FTP INDIGO: LOT# UNK| CARTRIDGE: MODEL SFC-25 FP |