FDA Adverse Event
Injury
Summary report: N
SEE H-10
MDR report key: 2141876
·
Received June 28, 2011
Report
- Report Number
- 2023826-2011-00568
- Event Type
- Injury
- Date Received
- June 28, 2011
- Date of Event
- May 18, 2011
- Report Date
- June 1, 2011
- Manufacturer
- STAAR SURGICAL COMPANY
- Product Code
- HQL
- PMA / PMN Number
- P990013
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCULAR LENS. (B)(4) - SURGICAL PROCEDURE, INCISION SUTURED, LENS (IOL), TORN, SPLIT, CRACKED. (B)(4). LENS NOT RETURNED.
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE REPORTER STATED THE SURGEON INSERTED A CC4204A COLLAMER ASPHERIC SINGLE PIECE LENS AND THE LENS TORE. THE LENS WAS REMOVED WITH NO PATIENT INJURY. ANOTHER SAME MODEL LENS WAS IMPLANTED AND SUTURE WAS REQUIRED. THE REPORTER STATED THE LENS DAMAGE WAS DUE TO LOADING.
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 | 71 YR | INJECTOR SYSTEM: MODEL NANOPOINT - LOT NUMBER UNK |