FDA Adverse Event
Injury
Summary report: N
VISIAN ICL (IMPLANTABLE COLLAMER LENS)
MDR report key: 1850954
·
Received September 28, 2010
Report
- Report Number
- 2023826-2010-00975
- Event Type
- Injury
- Date Received
- September 28, 2010
- Report Date
- August 30, 2010
- Manufacturer
- STAAR SURGICAL CO.
- Product Code
- MTA
- PMA / PMN Number
- P030016
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). EVAL RESULTS: A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINTS WERE FOUND WITHIN THE SAME WORK ORDER. (B)(4).
Description of Event or Problem · 1
THE REPORTER STATED THE SURGEON IMPLANTED A MICL 12.6 MM IMPLANTABLE COLLAMER LENS ON (B)(6)2010. PT DEVELOPED PERSISTANT ELEVATED INTRAOCULAR PRESSURE FOR TWO MONTHS. PT WAS PRESCRIBED IOP LOWERING DROPS BUT WAS NON COMPLIANT WITH THE MEDICATION. PT HAS BEEN ON STEROIDS DUE TO PRE-EXISTING CONDITION. THE PT WENT TO ANOTHER SURGEON AND THE ICL REMOVED. THIS, HOWEVER, DID NOT RESOLVE THE PROBLEM AND PT'S IOP IS STILL ELEVATED. DURING THE REMOVAL OF THE ICL, THE ICL WAS NOTED TO BE POSITIONED AND SIZED WELL WITH NO EXCESSIVE OR INADEQUATE VAULTING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VISIAN ICL (IMPLANTABLE COLLAMER LENS) | INTRAOCULAR LENS | MTA | STAAR SURGICAL CO. | MICL12.6 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | INJECTOR MODEL -MSI-PF - LOT # UNK| CARTRIDGE MODEL SFC-45 FP - LOT # UNK| FOAM TIP PLUNGER MODEL - LOT # UNK |