FDA Adverse Event
Malfunction
Summary report: N
COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL
MDR report key: 2073678
·
Received April 13, 2011
Report
- Report Number
- 2023826-2011-00325
- Event Type
- Malfunction
- Date Received
- April 13, 2011
- Date of Event
- March 16, 2011
- Report Date
- March 17, 2011
- Manufacturer
- STAAR SURGICAL COMPANY
- Product Code
- HQL
- PMA / PMN Number
- P990013
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE SURGEON INSERTED AN (B)(4) COLLAMER PLATE LENS AND THE LENS TORE AS IT WAS DELIVERED INTO THE EYE. THE LENS WAS REMOVED AND REPLACED WITHOUT ANY PT INJURY. THE REPORTER STATED THIS WAS THE FIRST TIME THIS FACILITY LOADED THE NANOPOINT INJECTOR AND IT WAS LIKELY IT WAS LOADED INCORRECTLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL | INTRAOCULAR LENS | HQL | STAAR SURGICAL COMPANY | CC4204A | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | NANOPOINT INJECTION SYSTEM: LOT NUMBER UNK| NANOPOINT INJECTION SYSTEM: LOT NUMBER UNK |