FDA Adverse Event
Malfunction
Summary report: N
SEE H-10
MDR report key: 2181888
·
Received July 28, 2011
Report
- Report Number
- 2023826-2011-00664
- Event Type
- Malfunction
- Date Received
- July 28, 2011
- Date of Event
- June 27, 2011
- Report Date
- June 27, 2011
- 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
RESULTS: VISUAL INSPECTION OF THE RETURNED LENS SHOWED THE LENS WAS RETURNED IN LIQUID AND THE OPTIC WAS TORN. (B)(4).
Additional Manufacturer Narrative · 1
COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCULAR LENS WITH ASPHERIC. (B)(4).
Description of Event or Problem · 1
THE REPORTER STATED THE SURGEON ATTEMPT TO INSERT A (B)(4) COLLAMER SINGLE PIECE LENS AND THE LENS WOULD NOT ADVANCE IN THE INJECTOR AND TORE. THERE AS PATIENT CONTACT BUT THE LENS WAS NOT IMPLANTED. THE REPORTER STATED THE INCIDENT WAS THE RESULT OF 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 | NANOPOINT INJECTION SYSTEM, LOT NUMBER UNK |