MAUDE Adverse Event Report: CARL ZEISS MEDITEC AG (OBERKOCHEN) EYEMAG LIGHT II; LIGHT, EXAMINATION, MEDICAL, BATTERY POWERED

Catalog Number 304121-9005-000

Device Problems Thermal Decomposition of Device (1071); Fire (1245); Smoking (1585)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/15/2022

Event Type  malfunction  

Event Description

A healthcare professional (hcp) reported that he reactivated the eyemag light ii by charging the battery.The eyemag light ii hasn't been used for almost two years.The first battery charged without any issues, but the second battery released smoke with fire after about four hours of charging.There was no adverse impact to anyone.

Manufacturer Narrative

Zeiss is the current legal manufacturer for the device eyemag light ii.However, the affected eyemag light ii was manufactured by the company schott at least 2 years ago, before zeiss became the legal manufacturer.

Manufacturer Narrative

Additional narrative: the affected device was from the old batch (manufactured in 2013 to 2016).The battery has been changed with a 0v charging protection since 2017, therefore no corrective action is required for the current manufacturing product.For the battery manufactured in 2013 to 2016, the worst case of deep discharge was simulated, which didn't indicate any safety risk in the practical usage.This issue is a single case and have no sign of significant occurrence.Based on the information reviewed, there is no evidence to indicate the presence of a potential quality issue with respect to current manufacturing, design or labeling.Following the risk-based approach, no further corrective action is required.Corrected data: h3: device evaluated by manufacturer? changed from no, to yes.Evaluation summary attached.H6: type of investigation: added 10, testing of actual/suspected device; 11, testing of device from same lot/batch retained by manufacturer; 4113, device not manufactured by reporting manufacturer; investigation findings: changed from 3233 (results pending completion of investigation) to 135, degradation problem identified; 3227, power source problem identified; 4216, overheating problem identified; investigation conclusions: changed from 11 (conclusion not yet available) to 18, failure to follow instructions; 4301, design inadequate for purpose; h10: added manufacturer narrative.

• Brand Name: EYEMAG LIGHT II
• Type of Device: LIGHT, EXAMINATION, MEDICAL, BATTERY POWERED
• 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: manjaya hegde ; 5300 central parkway; dublin, CA 94568 ; 9255574100
• MDR Report Key: 13476984
• MDR Text Key: 287826594
• Report Number: 9615010-2022-00001
• Device Sequence Number: 1
• Product Code: KYT
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 304121-9005-000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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