FDA Adverse Event
Injury
Summary report: N
COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA
MDR report key: 2082845
·
Received May 3, 2011
Report
- Report Number
- 2023826-2011-00363
- Event Type
- Injury
- Date Received
- May 3, 2011
- Date of Event
- March 16, 2011
- Report Date
- April 14, 2011
- Manufacturer
- STAAR SURGICAL COMPANY
- Product Code
- HQL
- PMA / PMN Number
- P990013
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- PHYSICIAN ASSISTANT
Narratives
Additional Manufacturer Narrative · 1
(B)(4), INCISION SUTURED. RESULTS - (OTHER): VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND PIECES OF THE OPTIC AND A LOOP HAPTIC TORN OFF AND MISSING. LENS WAS RETURNED IN LIQUID. (B)(4).
Description of Event or Problem · 1
THE REPORTER STATED THE SURGEON INSERTED A (B)(4) COLLAMER ASPHERIC THREE PIECE LENS. LENS TORE ON INSERTION INTO THE EYE. NO WIDENED INCISION, SUTURES WERE USED TO CLOSE THE WOUND. REPORTER STATED INCIDENT WAS DUE TO LOADING ERROR. THREE LENSES WERE USED ON SAME PT, SAME EYE. THIS REPORT IS FOR THE SECONDARY LENS. SEE MFR #2023826-2011-00364 FOR PRIMARY LENS. A THIRD LENS, SAME MODEL AND SIZE 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 COMPANY | CQ2015A | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Required Intervention | CARTRIDGE: MODEL-CQ CARTRIDGE-FP,| INJECTOR: MODEL-MSI-PM, LOT NUMBER 1258183| LOT NUMBER 1259972 |