FDA Adverse Event
Injury
Summary report: N
ICL (IMPLANTABLE COLLAMER LENS)
MDR report key: 6179667
·
Received December 15, 2016
Report
- Report Number
- 2023826-2016-01774
- Event Type
- Injury
- Date Received
- December 15, 2016
- Report Date
- November 16, 2016
- Manufacturer
- STAAR SURGICAL COMPANY
- Product Code
- MTA
- PMA / PMN Number
- P030016
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
WORK ORDER SEARCH: NO SIMILAR CLAIM WAS REPORTED FOR UNITS WITHIN THE SAME LOT. (B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE PATIENT REPORTED THE SURGEON IMPLANTED A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -10.5 DIOPTER, IN HER LEFT EYE (OS). THE PATIENT REPORTED A HALO FOGGY RING AROUND LIGHTS WHEN IT IS DARK, CAUSING ISSUES WHEN DRIVING. THE LENS WAS IMPLANTED ON (B)(6) 2011 AND REMAINS IMPLANTED. THE PATIENT HAS NOT SEEN A DOCTOR IN OVER THREE YEARS AND NO MORE INFORMATION WAS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 827985 | ICL (IMPLANTABLE COLLAMER LENS) | INTRAOCULAR LENS | MTA | STAAR SURGICAL COMPANY | MICL13.2 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |