FDA Adverse Event
Injury
Summary report: N
ICL (IMPLANTABLE COLLAMER LENS)
MDR report key: 6048775
·
Received October 21, 2016
Report
- Report Number
- 2023826-2016-01107
- Event Type
- Injury
- Date Received
- October 21, 2016
- Date of Event
- February 11, 2016
- Report Date
- May 17, 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
- KS
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(6). DEVICE EVALUATION: PRODUCT EVALUATION FOUND THAT THE LENS WAS RETURNED DRY IN THE LENS CONTAINER. VISUAL INSPECTION FOUND NO VISIBLE DAMAGE TO LENS, BUT THERE WAS FOREIGN MATERIAL ON LENS SURFACE SPECIFIED AS DRIED, DISCOLORED MATERIAL. (B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE REPORTER INDICATED THAT THE SURGEON INSERTED A 11.5MM ICM115V4 IMPLANTABLE COLLAMER LENS, -12.50 DIOPTER, IN THE PATIENT'S RIGHT EYE ON (B)(6) 2015. 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 700140 | ICL (IMPLANTABLE COLLAMER LENS) | INTRAOCULAR LENS | MTA | STAAR SURGICAL COMPANY AG | ICM115V4 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 32 YR | Required Intervention |