FDA Adverse Event
Other
Summary report: N
VISIAN ICL (IMPLANTABLE COLLAMER LENS)
MDR report key: 1318386
·
Received February 19, 2009
Report
- Report Number
- 2023826-2009-00153
- Event Type
- Other
- Date Received
- February 19, 2009
- Date of Event
- January 20, 2009
- Report Date
- January 23, 2009
- Manufacturer
- STAAR SURGICAL CO.
- Product Code
- MTA
- PMA / PMN Number
- P030016
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
EVALUATION: RESULTS: VISUAL INSPECTION OF THE RETURNED PRODUCT SHOWED THAT ONE HAPTIC PLATE WAS TORN AND A PIECE OF THE OTHER HAPTIC WAS TORN OFF AND MISSING. THERE WAS A CLEAR SURGICAL RESIDUE ON THE LENS.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE SURGEON INSERTED A MICL12.6 IMPLANTABLE COLLAMER LENS AND THE LENS TORE UPON INSERTION. THE LENS WAS REMOVED WITHOUT ANY PT INJURY. THE RPTR STATED HE INADVERTENTLY REUSED THE CARTRIDGE, WHICH RESULTED IN THE LENS TEAR. THIS IS THE SECOND LENS THE SURGEON ATTEMPTED TO IMPLANT IN THIS PT (SEE MFR REPORT #2023826-2009-00152). A NEW CARTRIDGE WAS USED AND THE THIRD LENS WAS SUCCESSFULLY IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VISIAN ICL (IMPLANTABLE COLLAMER LENS) | INTRAOCULAR LENS | MTA | STAAR SURGICAL CO. | MCL12.6 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | INJECTOR: MODEL MSI-PF| CARTRIDGE: MODEL SFC-45 FP| FOAM TIP PLUNGER: MODEL |