FDA Adverse Event
Injury
Summary report: N
CARTRIDGE, 2.5MM RHOMBUS
MDR report key: 37668
·
Received September 5, 1996
Report
- Report Number
- 2027189-1996-00002
- Event Type
- Injury
- Date Received
- September 5, 1996
- Date of Event
- August 6, 1996
- Report Date
- September 5, 1996
- Manufacturer
- CHIRON VISION CORP.
- Product Code
- HQL
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
F8: NA - MFR DID NOT RECEIVE A MEDWATCH REPORT FROM THE USER FACILITY. F10: PATIENT CODE (CORRECTED) - 2200 (OTHER) INCISION ENLARGEMENT, UNLABELED. F10: DEVICE CODE - 1628, UNLABELED. G4: INFORMATION CORRECTED TO DATE THAT MFR RECEIVED INFORMATION THAT MADE THE COMPLAINT "REPORTABLE".
Description of Event or Problem · 1
THE DR INSERTED THE LENS DELIVERY CARTRIDGE INTO THE EYE AND UPON ADVANCING THE PLUNGER, THE LENS TORE PROXIMAL TO THE OPTIC ON THE TRAILING HAPTIC. AND INCISION ENLARGMENT FROM 3.5 MM TO APPROX 5.0 MM WAS REQUIRED TO REMOVE THE LENS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CARTRIDGE, 2.5MM RHOMBUS | INSERTION DEVICES | HQL | CHIRON VISION CORP. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 88 YR | Required Intervention | AMVISC PLUS VISCOELEASTIC| C10UB INTRAOCULAR LENS | |
| 2 |