FDA Adverse Event Malfunction Summary report: N

ALCON

MDR report key: 26827 · Received January 17, 1995

Report

Report Number: 26827
Event Type: Malfunction
Date Received: January 17, 1995
Report Date: July 6, 1994
Manufacturer: ALCON SURGICAL, INC.
Product Code: HKP
Product Problem: Yes
Report Source: User Facility report

Narratives

Description of Event or Problem · 1

DURING CATARACT SURGERY, PHYSICIAN NEEDED TO PERFORM A VITRECTOMY. THE VITRECTOR WAS OPENED, CONNECTED, BUT DID NOT CUT - ANOTHER VITRECTOR WAS OPENED AND USED. NO INJURY/HARM TO PATIENT. REPORT SUBMITTED TO FDA AND USP.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD. INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: INVALID DATA. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: NO DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ALCON	ADVANCED TECHNOLOGY IRRIGATING OCUTOME PROBE	HKP	ALCON SURGICAL, INC.

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK		Other