FDA Adverse Event
Injury
Summary report: N
SOVEREIGN COMPACT CONSOLE UNIVERSAL
MDR report key: 2042094
·
Received March 29, 2011
Report
- Report Number
- 2020664-2011-00005
- Event Type
- Injury
- Date Received
- March 29, 2011
- Date of Event
- February 28, 2011
- Report Date
- February 28, 2011
- Manufacturer
- ABBOTT MEDICAL OPTICS(AMO)
- Product Code
- HQC
- PMA / PMN Number
- K003638
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). UPON INSPECTION AND ANALYSIS OF THE PHACOEMULSIFICATION UNIT ON (B)(6) 2011 WAS PERFORMED BY AN AMO SERVICE TECHNICIAN. IT WAS FOUND THAT THE ORIGINAL PROBLEM COULD NOT BE DUPLICATED. HANDPIECES WERE CHECKED AND FELL WITHIN THE PROPER VOLTAGES. THE UNIT PASSED ALL FUNCTIONAL CHECKOUTS AND MEETS AMO SPECIFICATION. NO ADDITIONAL INFORMATION WAS PROVIDED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A CATARACT PROCEDURE THERE WAS CHAMBER SHALLOWING WHICH RESULTED IN A POSTERIOR CAPSULAR TEAR. A VITRECTOMY WAS PERFORMED. THE PT HAD AN INCISION ENLARGED WHICH REQUIRED SUTURING. THE CLINIC INDICATED EXPECTED PT OUTCOME IS GOOD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SOVEREIGN COMPACT CONSOLE UNIVERSAL | HQC | ABBOTT MEDICAL OPTICS(AMO) | CMP680300 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Required Intervention |