FDA Adverse Event
Malfunction
Summary report: N
SEE H-10
MDR report key: 2162705
·
Received July 15, 2011
Report
- Report Number
- 2023826-2011-00611
- Event Type
- Malfunction
- Date Received
- July 15, 2011
- Date of Event
- June 21, 2011
- Report Date
- June 22, 2011
- Manufacturer
- STAAR SURGICAL COMPANY
- Product Code
- HQL
- PMA / PMN Number
- P990013
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCULAR LENS. (B)(4). LENS NOT RETURNED. (B)(4).
Additional Manufacturer Narrative · 1
(B)(4) VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND A PIECE OF ONE HAPTIC TORN OFF AND MISSING. THE LENS WAS RETURNED IN LIQUID. (B)(4)
Description of Event or Problem · 1
THE REPORTER STATED THE SURGEON WAS INSERTING A (B)(4) COLLAMER ASPHERIC SINGLE PIECE LENS AND THE LENS TORE DUE TO HAVING BEEN LOADED INCORRECTLY. THERE WAS PATIENT CONTACT BUT NO INJURY. THE REPORTER STATED IT WAS DUE TO A LOADING ERROR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SEE H-10 | INTRAOCULAR LENS | HQL | STAAR SURGICAL COMPANY | CC4204A | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | INJECTOR SYSTEM MODEL NANOPOINT - LOT NUMBER UNK |