FDA Adverse Event
Malfunction
Summary report: N
SEE H-10
MDR report key: 2052365
·
Received April 12, 2011
Report
- Report Number
- 2023826-2011-00319
- Event Type
- Malfunction
- Date Received
- April 12, 2011
- Date of Event
- March 16, 2011
- Report Date
- March 16, 2011
- Manufacturer
- STAAR SURGICAL COMPANY
- Product Code
- HQL
- PMA / PMN Number
- P990013
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCULAR LENS.(B)(4): LENS REMAINS IMPLANTED.
Description of Event or Problem · 1
THE REPORTER STATED THE TECHNICIAN LOADED A CC4204A COLLAMER ASPHERIC SINGLE PIECE LENS AND CRACKS WERE FOUND IN THE LENS. THE LENS WAS IMPLANTED AND THE PATIENT'S VISION WAS NOT AFFECTED. THERE WAS NO PATIENT INJURY. THE REPORTER STATED MOST LIKELY THE CAUSE OF THE CRACKS IN THE LENS WAS DUE TO THE TYPE OF FORCEPS BEING USED AND THE LOADING TECHNIQUE. THE REPORTER STATED THE NURSING STAFF WAS RETRAINED AND THE PROBLEM WITH THE LENS CRACKING HAS BEEN RESOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SEE H-10 | INTRAOCULAR LENS | HQL | STAAR SURGICAL COMPANY | CC4204A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | CARTRIDGE MODEL SFC-25 FP - LOT NUMBER UNK| INJECTOR MODEL INDIGO-P - LOT NUMBER UNK| FOAM TIP PLUNGER MODEL FTP INDIGO - LOT NUMBER UNK |