FDA Adverse Event
Injury
Summary report: N
ICL (IMPLANTABLE COLLAMER LENS)
MDR report key: 1840907
·
Received September 15, 2010
Report
- Report Number
- 2023826-2010-00926
- Event Type
- Injury
- Date Received
- September 15, 2010
- Date of Event
- September 1, 2010
- Report Date
- September 9, 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
- AR
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4)- SECONDARY SURGERY, (B)(4).
Description of Event or Problem · 1
THE REPORTER STATED THE SURGEON IMPLANTED AN 12.5MM ICM125V4 IMPLANTABLE COLLAMER LENS ON (B)(6)2010, IN PT'S LEFT EYE. THE LENS WAS EXPLANTED ON (B)(6)2010, DUE TO EXCESSIVE VAULTING WITH ELEVATED IOP. THE PT'S VISION WAS BLURRY. THE LENS WAS EXCHANGED FOR A SHORTER LENS. CURRENTLY, THERE IS OCCASIONAL PHOTOPHOBIA AND SOME INFLAMMATION ON THE INCISION USED FOR EXPLANTATION. IOP IS NORMAL AND USING DROPS FOR INFLAMMATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ICL (IMPLANTABLE COLLAMER LENS) | INTRAOCULAR LENS | MTA | STAAR SURGICAL CO. | ICM125 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR | Required Intervention | INJECTOR MODEL AND LOT # UNK| FOAM TIP PLUNGER MODEL AND LOT # UNK| CARTRIDGE MODEL AND LOT # UNK |