N
Patient 1
THE PRODUCT HAS BEEN REQUESTED FOR EVALUATION HOWEVER IT HAS NOT YET BEEN RECEIVED.
MAUDE MDR 5675712
- MDR report key
- 5675712
- Report number
- 0001920664-2016-00173
- Event key
- 0
- Event type
- 3
- Date received
- 2016-05-24
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MS. SHARON SPENCER
- Address
- 50 TECHNOLOGY DRIVE WEST IRVINE CA 92618 US
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | STORZ INSTRUMENT | CAPSULORHEXIS TIP SHORT | BAUSCH + LOMB | HNY | ET1088TS | Y | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2016-05-24 | 0 | 1. O |
Event Narratives#
D
Patient 1
DURING SURGERY THE TIP OF THE CLAMP IS BROKEN IN TWO IN THE PATIENT EYE. THE PIECE HAS BEEN REMOVED FROM THE EYE. NO CLINICAL IMPACT FOR THE PATIENT. PRODUCT REQUESTED. PATIENT OKAY.
N
Patient 1
THE INSTRUMENT WAS VISUALLY INSPECTED UNDER A MICROSCOPE. THERE WAS NO EVIDENCE OF A MATERIAL DEFECT OR A MANUFACTURING ERROR. THE INSTRUMENT IS BROKEN. ONE JAW OF THE INSTRUMENT BROKE OFF. THE INSTRUMENT APPEARED AS THOUGH IT HAS NOT BEEN CLEANED. UNABLE TO DETERMINE HOW OR WHEN THIS INSTRUMENT BROKE.