MAUDE Adverse Event Report: CARL ZEISS MEDITEC AG (JENA) 700; BIOMICROSCOPE, SLIT-LAMP, AC-POWERED

Model Number 700

Device Problem Incorrect Measurement (1383)

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

Event Date 09/27/2022

Event Type  malfunction  

Event Description

Malfunction was reported on device by health care professional (hcp).Axial length (al) was found to be out of tolerance after review of device logfiles.Wrong al measurement data were not used for surgery.No injuries were reported.

Manufacturer Narrative

Descriptions of changes: field g3: updated "date received by manufacturer " field g6: updated to "follow-up #: 1" field h2 : selected "device evaluation" field h3: updated to "yes".Checked "evaluation summary attached" box field h6: added type of investigation to "10".Updated investigation conclusions to "4316".Field h10: added description of changes.Preferred term for h6 investigation conclusions: would be "field service engineer error".

• Brand Name: 700
• Type of Device: BIOMICROSCOPE, SLIT-LAMP, AC-POWERED
• Manufacturer (Section D): CARL ZEISS MEDITEC AG (JENA); carl zeiss promenade 10; jena, thueringia 7745 ; GM 7745
• Manufacturer (Section G): CARL ZEISS MEDITEC AG (JENA); carl zeiss promenade 10; jena, thueringia 7745 ; GM 7745
• Manufacturer Contact: manjaya hegde ; 5300 central parkway; dublin, CA 94568 ; 9252164697
• MDR Report Key: 15762296
• MDR Text Key: 305248789
• Report Number: 9615030-2022-00009
• Device Sequence Number: 1
• Product Code: HJO
• UDI-Device Identifier: 04049471092080
• UDI-Public: (01)04049471092080(11)200901
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K170171
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 700
• Device Catalogue Number: 000000-1932-169
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2020
• 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): Life Threatening