FDA Adverse Event
Injury
Summary report: N
ICL (IMPLANTABLE COLLAMER LENS)
MDR report key: 6077381
·
Received November 3, 2016
Report
- Report Number
- 2023826-2016-01531
- Event Type
- Injury
- Date Received
- November 3, 2016
- Date of Event
- April 2, 2016
- Report Date
- October 11, 2016
- Manufacturer
- STAAR SURGICAL COMPANY
- Product Code
- MTA
- PMA / PMN Number
- NA
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
PMA/510(K) : NA THIS PRODUCT IS MANUFACTURED IN THE U.S. BUT NOT MARKETED IN THE U.S. (B)(4).
Additional Manufacturer Narrative · 1
ADDITIONAL DATA: DEVICE EVALUATION: PRODUCT EVALUATION FOUND THE LENS RETURNED DRY IN THE LENS CONTAINER, BUT THERE IS CLEAR SURGICAL RESIDUE/DEBRIS ON PRODUCT. VISUAL INSPECTION FOUND NO VISIBLE DAMAGE TO LENS. (B)(4).
Description of Event or Problem · 1
THE REPORTER INDICATED THE SURGEON IMPLANTED A 12.5MM TICM125V4 IMPLANTABLE COLLAMER LENS - -18.5/+2.0/90 DIOPTER, IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2008. THE LENS WAS EXPLANTED ON (B)(6) 2016 DUE TO LOW VAULT AND CATARACT. THE LENS WAS EXCHANGED FOR A LONGER LENS AND THE PROBLEM WAS RESOLVED. THE PATIENT'S POST-OP BEST CORRECTED VISUAL ACUITY WAS 20/15.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 727132 | ICL (IMPLANTABLE COLLAMER LENS) | PHAKIC INTRAOCULAR LENS | MTA | STAAR SURGICAL COMPANY | TICM125V4 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 23 YR | Required Intervention |