MAUDE Adverse Event Report: CARL ZEISS MEDITEC, INC. IOL MASTER 700 SERIAL NUMBER 1185213; BIOMICROSCOPE, SLIT-LAMP, AC-POWERED

Model Number 700

Device Problems Device Difficult to Program or Calibrate (1496); Product Quality Problem (1506); Incorrect, Inadequate or Imprecise Result or Readings (1535); Battery Problem (2885); Device Fell (4014)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/22/2020

Event Type  malfunction  

Event Description

We have an iol master 700 made by carl zeiss meditec with serial number (b)(4).After 4 year, the internal battery failed, and require replacement.During the battery replacement, the service tech (b)(4) tilt the device, the internal mirror/lens on the fru keratometry fell down,.Even this was created by the movement of zeiss technician, zeiss is charging us (b)(6) to fix it.The internal mirror appear was poorly made and poorly attached, and easily to fall during the movement.The part fall was fru keratometer unit.The part number is 000000000002216789.We demonstrated all tests done this month before our battery failed, had passed calibration of keratometry.This demonstrate the mirror was attached and function normally until the battery replacement by zeiss service tech.When mirror fell after battery replacement, we cannot pass calibration of keratometer during the trial test for zeiss tech (b)(4).On (b)(6) 2020 replacement of internal battery of zeiss iol master 700, mirror fell, internal lens of keratometer was poorly mounted, or zeiss tech moved the iol master too hard.This internal lens fell reflected either the internal lens was poorly made, and poorly mounted; or the zeiss tech dropped the mirror too hard.The design of the iop master do not allow physician customer to change the battery their selves.Several hundreds dollar to replace the battery, which then generate another (b)(6) for zeiss.We felt the quality of keratometry lens should be investigated.The durability was not tested when iol master 700 was approved by fda.Zeiss manager claimed that even we caused the mirror/or internal lens to fall down during our repair, it is still the customer's responsibility.We felt this philosophy is not acceptable.Our iol master 700 was functioned normally until battery was replaced by zeiss.We were able to calibrate normally.Calibrate normally require both internal lens/mirrors to be mounted and in place.This prove the keratometry lens in our units were both in place and mounted before battery replacement.Either lens dislocation would result inability to pass the calibration.Fda safety report id# (b)(4).

• Brand Name: IOL MASTER 700 SERIAL NUMBER 1185213
• Type of Device: BIOMICROSCOPE, SLIT-LAMP, AC-POWERED
• Manufacturer (Section D): CARL ZEISS MEDITEC, INC. ; dublin CA
• MDR Report Key: 10338323
• MDR Text Key: 201074337
• Report Number: MW5095777
• Device Sequence Number: 1
• Product Code: HJO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 700
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/28/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 60 YR