FDA Adverse Event
Malfunction
Summary report: N
SEE H-10
MDR report key: 4045806
·
Received August 28, 2014
Report
- Report Number
- 2023826-2014-00677
- Event Type
- Malfunction
- Date Received
- August 28, 2014
- Date of Event
- August 11, 2014
- Report Date
- August 11, 2014
- Manufacturer
- STAAR SURGICAL COMPANY
- Product Code
- HQL
- PMA / PMN Number
- P990013
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NM, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EVALUATION RESULTS - VISUAL INSPECTION OF THE RETURNED PRODUCT SHOWED BOTH THE LENS AND INJECTOR PLUNGER WAS STUCK IN THE CARTRIDGE AND THERE WAS A CLEAR SURGICAL RESIDUE ON THE DEVICES. THE LAF CARD WAS PROVIDED WITH THE PATIENT INFORMATION.(B)(4).
Additional Manufacturer Narrative · 1
COLLAMER®ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCULAR LENS. (B)(4).
Description of Event or Problem · 1
THE REPORTER STATED THAT THE HAPTIC OF THE 23.5 DIOPTER CC4204A COLLAMER SINGLE PIECE LENS WAS DAMAGED DURING INSERTION INTO THE PATIENTS EYE. THE LENS WAS REMOVED WITHOUT ANY PATIENT INJURY. THE CAUSE OF THE EVENT WAS A TECH ERROR. THE TECH HAS BEEN RE-TRAINED SINCE THE INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 527221 | SEE H-10 | INTRAOCULAR LENS | HQL | STAAR SURGICAL COMPANY | CC4204A | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR |