ICL (IMPLANTABLE COLLAMER LENS)
Report
- Report Number
- 2023826-2014-00366
- Event Type
- Injury
- Date Received
- May 15, 2014
- Report Date
- April 14, 2014
- Manufacturer
- STAAR SURGICAL COMPANY
- Product Code
- MTA
- PMA / PMN Number
- P030016
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UP
- Reporter Occupation
- PHYSICIAN
Narratives
(B)(4) - NO INFORMATION. DEVICE EVALUATED BY MANUFACTURER? NO. LENS IMPLANTED. (B)(4).
METHOD: MEDICAL REVIEW. RESULTS: MEDICAL REVIEW - PIGMENT DISPERSION MAY BE ORIGINATED FROM PRE-EXISTING CONCAVE IRIS ANATOMY, INFLAMMATION, TRAUMA, OR MECHANICAL CONTACT OF IOLS AND IRIS. LATE ELEVATED IOP MAY OCCUR AS RESULT OF CHRONIC NARROW ANGLES, PIGMENT DISPERSION, INFLAMMATION, ETC. CONCLUSIONS: BASED ON THE COMPLAINT HISTORY AND MEDICAL REVIEW, A SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. (B)(4).
THE REPORTER INDICATED THE SURGEON IMPLANTED AN ICL IMPLANTABLE COLLAMER LENS IN THE PATIENT'S LEFT EYE (OS) IN 2012. THE PATIENT CAME IN FOR A POST-OP VISIT WITH PIGMENT DISPERSION SYNDROME AND SECONDARY GLAUCOMA. THE ICL IS OK, THE VAULT IS 300 - 350, NOT TOO HIGH. THE PATIENT WAS PUT ON ANTI-GLAUCOMA DROPS. TODAY HE IS COMPENSATED (IOP 15-17). THE LENS REMAINS IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 290503 | ICL (IMPLANTABLE COLLAMER LENS) | INTRAOCULAR LENS | MTA | STAAR SURGICAL COMPANY | UNK | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | INJECTOR MODEL AND LOT NUMBER UNK| CARTRIDGE MODEL AND LOT NUMBER UNK |