MAUDE Adverse Event Report: CARL ZEISS MEDITEC, INC. ZEISS UNIVERSAL S3 OPMI SURGICAL MICROSCOPE; MICROSCOPE, OPERATING & ACCESSORIES, AC-POWERED, OPHTHALMIC

Model Number UNIVERSAL S3

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/28/2016

Event Type  malfunction  

Event Description

Microscope malfunctioned during cataract surgery.No injury.Surgery completed using manual manipulation.

• Brand Name: ZEISS UNIVERSAL S3 OPMI SURGICAL MICROSCOPE
• Type of Device: MICROSCOPE, OPERATING & ACCESSORIES, AC-POWERED, OPHTHALMIC
• Manufacturer (Section D): CARL ZEISS MEDITEC, INC.; william g. gustafson; 5160 hacienda drive; dublin CA 94568
• MDR Report Key: 6050292
• MDR Text Key: 58148533
• Report Number: 6050292
• Device Sequence Number: 1
• Product Code: HRM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: UNIVERSAL S3
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/10/2016
• Event Location: Hospital
• Date Report to Manufacturer: 10/10/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1