FDA Adverse Event
Injury
Summary report: N
ICL (IMPLANTABLE COLLAMER LENS)
MDR report key: 2130674
·
Received June 14, 2011
Report
- Report Number
- 2023826-2011-00526
- Event Type
- Injury
- Date Received
- June 14, 2011
- Date of Event
- February 22, 2011
- Report Date
- June 3, 2011
- Manufacturer
- STAAR SURGICAL CO.
- Product Code
- MTA
- PMA / PMN Number
- P030016
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). (B)(4).
Description of Event or Problem · 1
THE REPORTER STATED THE SURGEON IMPLANTED A 12.0MM ICM120V4 IMPLANTABLE COLLAMER LENS IN THE PATIENT'S LEFT EYE ON (B)(6) 2009. A POSTERIOR SUBCAPSULAR CATARACT WAS NOTED ON (B)(6) 2011. PATIENT EXPERIENCED LOSS OF VISUAL ACUITY AND BLURRED VISION. THE CATARACT WAS REMOVED AND THE LENS WAS EXPLANTED ON (B)(6) 2011.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ICL (IMPLANTABLE COLLAMER LENS) | INTRAOCULAR LENS | MTA | STAAR SURGICAL CO. | ICM120V4 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR | Required Intervention |