FDA Adverse Event
Injury
Summary report: N
ICL (IMPLANTABLE COLLAMER LENS)
MDR report key: 6124479
·
Received November 23, 2016
Report
- Report Number
- 2023826-2016-01641
- Event Type
- Injury
- Date Received
- November 23, 2016
- Date of Event
- July 13, 2016
- Report Date
- October 25, 2016
- Manufacturer
- STAAR SURGICAL COMPANY
- Product Code
- MTA
- PMA / PMN Number
- N/A
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KN
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
THIS PRODUCT IS MANUFACTURED IN THE U.S. BUT NOT MARKETED IN THE U.S. (B)(4).
Additional Manufacturer Narrative · 1
DEVICE EVALUATION: THE LENS WAS RETURNED DRY IN CASE/VIAL; SURGICAL RESIDUE WAS CLEAR; VISUAL INSPECTION FOUND HAPTIC BROKEN AND FIBERS ON LENS SURFACE. METHOD CODE; WORK ORDER SEARCH PERFORMED AND NO SIMILAR COMPLAINTS FOUND. (B)(4).
Description of Event or Problem · 1
THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2 MM VICMO13.2 IMPLANTABLE COLLAMER LENS, -08.50 DIOPTER IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2016 AND THE LENS WAS NOTED TO BE TORN. THE LENS WAS EXPLANTED ON (B)(6) 2016 AND EXCHANGED FOR A SHORTER LENS THE SAME MODEL AND DIOPTER AND THE PROBLEM WAS RESOLVED. THERE WAS NO REPORT OF ANY APPARENT INJURY. THE PATIENT'S POST-OP UNCORRECTED VISUAL ACUITY WAS 20/20.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 774990 | ICL (IMPLANTABLE COLLAMER LENS) | INTRAOCULAR LENS | MTA | STAAR SURGICAL COMPANY | VICMO13.2 | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 23 YR | Required Intervention |