VISIAN ICL (IMPLANTABLE COLLAMER LENS)
Report
- Report Number
- 2023826-2012-00829
- Event Type
- Injury
- Date Received
- October 24, 2012
- Date of Event
- February 19, 2009
- Report Date
- September 24, 2012
- Manufacturer
- STAAR SURGICAL COMPANY
- Product Code
- MTA
- PMA / PMN Number
- P030016
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- PHYSICIAN
Narratives
EVALUATION:METHOD - DEVICE HISTORY RECORD REVIEW.RESULTS - A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND NOTHING WAS FOUND IN THE MANUFACTURING PROCESS OF THIS LENS THAT WAS THE ROOT CAUSE OF THE COMPLAINT. CONCLUSIONS - BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH AND THE REVIEW OF THE DEVICE HISTORY RECORD, A SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED.(B)(4).
METHOD: MEDICAL REVIEW. RESULTS: MEDICAL REVIEW - REVIEW OF THIS FILE INDICATES THAT THE ICL EXHIBITED A LOW OR NO VAULT IN THIS PATIENT HOWEVER, WITH SIGNS OF ANTERIOR SUBCAPSULAR CATARACT. THE ICL WAS EXCHANGED WITH A LONGER LENS TO PREVENT PROGRESSION OF THE CATARACT. IT HAS BEEN DETERMINED THAT THIS COMPLICATION IS RELATED TO INACCURATE WHITE TO WHITE MEASUREMENT OR SECONDARY TO A MISMATCH BETWEEN WHITE TO WHITE AND THE SULCUS DIAMETER. SURGEONS ARE ADVISED TO OBSERVE THE PATIENT FOR ANY SIGNS OR SYMPTOMS OF PROGRESSIVE ANTERIOR SUBCAPSULAR CATARACT FORMATION PRIOR TO EXCHANGING THIS LENS. STAAR RECOMMENDS THAT THE LENS BE EXPLANTED ONCE THE SURGEON DETERMINES THAT THIS CONDITION MAY AFFECT OUTCOME OF THE PATIENT'S VISION. IF NO OTHER SYMPTOMS ARE OBSERVED, IT IS RECOMMENDED TO LEAVE THE ICL IMPLANTED. THE ICL IS INDICATED IN PATIENTS 21-45 YEARS OF AGE. THERE IS A MUCH GREATER RISK OF CATARACT IN PATIENTS OVER 45 YEARS OF AGE POST ICL IMPLANTATION. THE PATIENT IN THIS CASE IS (B)(6). ANTERIOR SUBCAPSULAR CATARACT IS A LABELED COMPLICATION IN THE IMPLANTATION OF AN ICL. CATARACT EXTRACTION MAY BE NECESSARY IF VISION IS COMPROMISED, TO PRECLUDE INCREASE IN SEVERITY OF THE CONDITION. IF THE CONDITION IS NON-PROGRESSIVE, THE SURGEON MAY OPT TO LEAVE THE ICL, ESPECIALLY WHEN THERE IS NO DECREASE IN VISUAL ACUITY. IN THE U.S. FDA CLINICAL TRIALS, APPROXIMATELY 6% TO 7% OF EYES DEVELOPED ANTERIOR SUBCAPSULAR OPACITIES AT 7 YEARS FOLLOWING ICL IMPLANTATION, BUT ONLY 1%-2% PROGRESSED TO CLINICALLY SIGNIFICANT CATARACT DURING THE SAME PERIOD. CATARACT EXTRACTION WAS PERFORMED IN THESE CASES AND VISUAL OUTCOME WAS GOOD. CONCLUSIONS: BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH, DEVICE HISTORY RECORD REVIEW AND MEDICAL REVIEW, THE ROOT CAUSE OF INADEQUATE VAULTING HAS BEEN DETERMINED TO BE RELATED TO THE INACCURACY OF THE WHITE TO WHITE MEASUREMENT OR A MISMATCH BETWEEN WHITE TO WHITE AND THE SULCUS TO SULCUS DIAMETER. ANOTHER POSSIBLE ROOT CAUSE HAS ALSO BEEN DETERMINED TO BE DUE TO THE OFF-LABEL USE OF THE LENS. (B)(4).
(B)(4) - CATARACT, INDUCED, (EXPLANTED). DEVICE EVALUATED BY MANUFACTURER? NO. LENS NOT RETURNED. EVALUATION: METHOD: WORK ORDER SEARCH. RESULTS: A LENS WORK ORDER SEARCH WAS PERFORMED AND THREE SIMILAR COMPLAINTS WERE FOUND WITHIN THE WORK ORDER. CONCLUSIONS (NO CONCLUSION CAN BE DRAWN): BASED ON THE COMPLAINT HISTORY AND THE WORK ORDER SEARCH, A SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. (B)(4). LENS NOT RETURNED.
THE REPORTER INDICATED THE SURGEON IMPLANTED A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2007. THE LENS WAS EXPLANTED ON (B)(6) 2009 DUE TO THE DEVELOPMENT OF A CATARACT. THE CATARACT WAS NOTED ON (B)(6) 2009. THE CATARACT WAS REMOVED AND AN IOL WAS IMPLANTED. THE PATIENT HAD PRK ON (B)(6) 2007.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VISIAN ICL (IMPLANTABLE COLLAMER LENS) | INTRAOCULAR LENS | MTA | STAAR SURGICAL COMPANY | MICL12.6 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR | Required Intervention | INJECTOR MODEL AND LOT NUMBER UNK| CARTRIDGE MODEL AND LOT NUMBER UNK |