FDA Adverse Event
Injury
Summary report: N
ICL (IMPLANTABLE COLLAMER LENS)
MDR report key: 6094189
·
Received November 10, 2016
Report
- Report Number
- 2023826-2016-01581
- Event Type
- Injury
- Date Received
- November 10, 2016
- Date of Event
- July 1, 2016
- Report Date
- October 11, 2016
- Manufacturer
- STAAR SURGICAL COMPANY AG
- Product Code
- MTA
- PMA / PMN Number
- P030016
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KN
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). SECONDARY SURGICAL INTERVENTION, LENS EXCHANGED FOR A LONGER LENS. (B)(4). LENS NOT RETURNED.
Additional Manufacturer Narrative · 1
DEVICE EVALUATION: THE LENS WAS RETURNED DRY IN CASE/VIAL; SURGICAL RESIDUE WAS CLEAR; VISUAL INSPECTION FOUND NO VISIBLE DAMAGE; MEASUREMENT WITHIN SPECIFICATIONS. (B)(4).
Description of Event or Problem · 1
THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 11.5 MM ICM115V4 IMPLANTABLE COLLAMER LENS, -13.50 DIOPTER IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2012. THE LENS WAS EXPLANTED ON (B)(6) 2016 DUE TO LOW VAULTING. THE LENS WAS EXCHANGED FOR A LONGER LENS AND THE PROBLEM WAS RESOLVED. THE PATIENT'S POST-OP BEST CORRECTED VISUAL ACUITY WAS 20/20.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 745614 | ICL (IMPLANTABLE COLLAMER LENS) | INTRAOCULAR LENS | MTA | STAAR SURGICAL COMPANY AG | ICM115V4 | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 22 YR | Required Intervention |