MAUDE Adverse Event Report: CARL ZEISS MEDITEC AG (OBERKOCHEN) OPMI VISU 210 ON S88 FLOORSTAND; MICROSCOPE, OPERATING & ACCESSORIES, AC-POWERED, OPHTHALMIC

Model Number VISU 210

Device Problems Device Operational Issue (2914); Optical Problem (3001)

Patient Problems Edema (1820); Eye Injury (1845); Capsular Bag Tear (2639)

Event Date 02/01/2018

Event Type  Injury  

Manufacturer Narrative

There is no evidence to show that the use of the microscope caused or contributed to the injuries reported.In the medsun mandatory and voluntary report form (b)(4) submitted to the fda, the site's risk program manager listed opmi vario as the device involved in the event.On march 5, 2018, the site's biomedical engineer confirmed that the device listed on the voluntary report is incorrect.The device that was involved in the incident was an opmi visu 210, serial number (b)(4).It was also learned that the device had been serviced by a third-party, not affiliated with zeiss.

Event Description

A health care professional (hcp) reported that the primary lamp of the opmi visu 210 on a s88 floor stand went out during a cataract extraction procedure.The hcp switched to the backup lamp; however, the light intensity of the backup lamp was not sufficient.It was reported that the patient sustained an iris prolapse, capsular tear, zonular dehiscence and corneal edema.

• Brand Name: OPMI VISU 210 ON S88 FLOORSTAND
• Type of Device: MICROSCOPE, OPERATING & ACCESSORIES, AC-POWERED, OPHTHALMIC
• Manufacturer (Section D): CARL ZEISS MEDITEC AG (OBERKOCHEN); rudolf-eber-strasse 11; oberkochen, baden-wuerttemberg 73447 ; GM 73447
• Manufacturer (Section G): CARL ZEISS MEDITEC AG (OBERKOCHEN); rudolf-eber-strasse 11; oberkochen, baden-wuerttemberg 73447 ; GM 73447
• Manufacturer Contact: william gustafson ; 5160 hacienda drive; dublin, CA 94568 ; 9255574689
• MDR Report Key: 7385684
• MDR Text Key: 103968546
• Report Number: 9615010-2018-00006
• Device Sequence Number: 1
• Product Code: HRM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: VISU 210
• Device Catalogue Number: 302606-9901-000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/28/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/27/2006
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 90 YR