FDA Adverse Event
Injury
Summary report: N
VENTURI PHACO PACK
MDR report key: 1080741
·
Received July 23, 2008
Report
- Report Number
- 1920664-2008-00767
- Event Type
- Injury
- Date Received
- July 23, 2008
- Date of Event
- June 30, 2008
- Report Date
- July 3, 2008
- Manufacturer
- BAUSCH & LOMB
- Product Code
- KYG
- PMA / PMN Number
- K980100
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
DURING CATARACT SURGERY THE DOCTOR ATTEMPTED TO INCREASE THE VACUUM IN THE DUAL SEGMENT REMOVAL WHICH RESULTED IN THE ANTERIOR CHAMBER COLLAPSING THREE TIMES. UPON THE SURGEONS INSPECTION OF THE IRRIGATION LINE THERE APPEARS TO BE A STRICTURE. THE ZONULE COLLAPSED AND A SUB-TENON INJECTION WAS ADMINISTERED FOR PAIN RELIEF. THE PT SUFFERED A SUBCHOROIDAL HAEMORRHAGE. THE PT HAS RECOVERED AND WILL BE ABLE TO PROCEED FOR FURTHER CORRECTIVE SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VENTURI PHACO PACK | OPHTHALMIC MICROSURGICAL ACCESSORY PACK | KYG | BAUSCH & LOMB | T9953 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 91 YR | Required Intervention |