IOLMaster 700Recalls & reported problems
Carl Zeiss Meditec AG · The IOLMaster 700 is intended for biometric measurements and visualization of ocular structures. The measurements and visualization assist in the determination of the appropriate power and type of intraocular lens. The IOLMaster 700 measures: • Lens thickness • Corneal curvature and thickness • Axial length • Anterior chamber depth • Pupil diameter • White-to-white distance (WTW) For visualization, the IOLMaster 700 employs optical coherence tomography (OCT) to obtain two-dimensional images of ocular structures of the anterior and posterior segments of the eye. The Reference Image functionality is intended for use as a preoperative and postoperative image capture tool. · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
The Carl Zeiss Meditec IOLMaster 700 is an eye measuring machine used before cataract surgery to help choose the right artificial lens. Most of the 50 reports describe measurements coming out wrong or off, sometimes leading to a lens implant that left patients needing a second operation, along with problems assembling or maintaining the unit. 43 reports involved injuries and no deaths were reported. One recall, started in June 2018 and closed, involved a calibration setting entered incorrectly during manufacturing that produced incorrect eye images.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 50
- Deaths reported
- 0
- Injuries reported
- 43
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 04049471092080), received between Jun 19, 2018 and Mar 13, 2026 — classified as 43 injuries, 7 malfunctions.
The most frequently reported specific device problem is “Use of Device Problem” (22 reports).
1 FDA recall record name this device's identifier.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Recalls naming this device
- Jun 25, 2018Terminated
Calibration setting was incorrectly entered during manufacturing causing the optical coherence tomography (OCT) to obtain the incorrect two-dimensional images of ocular structures of the anterior and posterior segments of the eye.
Z-0108-2019 · Root cause: Employee error · Recall details · FDA record ↗
Most reported problems
Device problems
- Use of Device Problem22
- Incorrect, Inadequate or Imprecise Result or Readings11
- Adverse Event Without Identified Device or Use Problem9
- Misassembly During Maintenance/Repair9
- Incorrect Measurement4
- Insufficient Device Problem Information3
- High Readings2
- Calibration Problem1
Patient problems
- Visual Impairment40
- No Clinical Signs, Symptoms or Conditions4
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available3
- Insufficient Information2
- No Patient Involvement1
Recent adverse event reports
The 25 most recent of 50 reports, in the reporter's own words as published by the FDA.
InjuryMar 13, 2026Insufficient Device Problem Information
THE CUSTOMER REPORTED THAT THEIR IOLMASTER 700 IS MEASURING THE CYLINDER (CYL) VALUE 1.5 DIOPTERS HIGHER THAN EXPECTED. A LENS REIMPLANTATION WAS PERFORMED FOR ONE PATIENT.
Patient problems: Visual Impairment
MAUDE report 24591210 ↗InjuryJan 15, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IOLMASTER 700 DEVICE MADE INCORRECT MEASUREMENTS FOR A PATIENT. THE PATIENT HAD 5 MEASUREMENT SESSIONS ON THE DEVICE. THE USER IMPLANTED AN IOL (INTRAOCULAR LENS) BASED ON MEASUREMENTS FROM (B)(6) 2025 WHICH RESULTED IN A HIGHLY HYPEROPIC ASTIGMATIC OUTCOME. THE USER IS PLANNING AN IOL EXCHANGE FOR THE PATIENT.
Patient problems: Visual Impairment
MAUDE report 24087315 ↗InjuryDec 18, 2025Incorrect, Inadequate or Imprecise Result or Readings; Misassembly During Maintenance/Repair; Incorrect, Inadequate or Imprecise Result or Readings; Misassembly During Maintenance/Repair
IT WAS REPORTED THAT A PATIENT IN IRELAND HAS HAD A RESULT OF -2 DIOPTERS SURGICAL OUTCOME FROM THE EXPECTED AND PLANNED SURGERY GOAL. IT IS VERY LIKELY THAT AN ADDITIONAL RE-OP (2ND SURGERY) WILL BE EXECUTED IN ORDER TO ACHIEVE THE PLANNED GOAL FOR THE PATIENT.
Patient problems: Visual Impairment
MAUDE report 23843952 ↗InjuryDec 18, 2025Incorrect, Inadequate or Imprecise Result or Readings; Misassembly During Maintenance/Repair; Incorrect, Inadequate or Imprecise Result or Readings; Misassembly During Maintenance/Repair
IT WAS REPORTED THAT A PATIENT IN IRELAND HAS HAD A RESULT OF -2 DIOPTERS SURGICAL OUTCOME FROM THE EXPECTED AND PLANNED SURGERY GOAL. IT IS VERY LIKELY THAT AN ADDITIONAL RE-OP (2ND SURGERY) WILL BE EXECUTED IN ORDER TO ACHIEVE THE PLANNED GOAL FOR THE PATIENT.
Patient problems: Visual Impairment
MAUDE report 23843711 ↗InjuryDec 18, 2025Incorrect, Inadequate or Imprecise Result or Readings; Misassembly During Maintenance/Repair; Incorrect, Inadequate or Imprecise Result or Readings; Misassembly During Maintenance/Repair
IT WAS REPORTED THAT A PATIENT IN IRELAND HAS HAD A RESULT OF -2 DIOPTERS SURGICAL OUTCOME FROM THE EXPECTED AND PLANNED SURGERY GOAL. IT IS VERY LIKELY THAT AN ADDITIONAL RE-OP (2ND SURGERY) WILL BE EXECUTED IN ORDER TO ACHIEVE THE PLANNED GOAL FOR THE PATIENT.
Patient problems: Visual Impairment
MAUDE report 23843458 ↗InjuryDec 18, 2025Incorrect, Inadequate or Imprecise Result or Readings; Misassembly During Maintenance/Repair; Incorrect, Inadequate or Imprecise Result or Readings; Misassembly During Maintenance/Repair
IT WAS REPORTED THAT A PATIENT IN IRELAND HAS HAD A RESULT OF -2 DIOPTERS SURGICAL OUTCOME FROM THE EXPECTED AND PLANNED SURGERY GOAL. IT IS VERY LIKELY THAT AN ADDITIONAL RE-OP (2ND SURGERY) WILL BE EXECUTED IN ORDER TO ACHIEVE THE PLANNED GOAL FOR THE PATIENT.
Patient problems: Visual Impairment
MAUDE report 23842830 ↗InjuryDec 18, 2025Incorrect, Inadequate or Imprecise Result or Readings; Misassembly During Maintenance/Repair; Incorrect, Inadequate or Imprecise Result or Readings; Misassembly During Maintenance/Repair
IT WAS REPORTED THAT A PATIENT IN IRELAND HAS HAD A RESULT OF -2 DIOPTERS SURGICAL OUTCOME FROM THE EXPECTED AND PLANNED SURGERY GOAL. IT IS VERY LIKELY THAT AN ADDITIONAL RE-OP (2ND SURGERY) WILL BE EXECUTED IN ORDER TO ACHIEVE THE PLANNED GOAL FOR THE PATIENT.
Patient problems: Visual Impairment
MAUDE report 23840714 ↗InjuryDec 18, 2025Incorrect, Inadequate or Imprecise Result or Readings; Misassembly During Maintenance/Repair; Incorrect, Inadequate or Imprecise Result or Readings; Misassembly During Maintenance/Repair
IT WAS REPORTED THAT A PATIENT IN IRELAND HAS HAD A RESULT OF -2 DIOPTERS SURGICAL OUTCOME FROM THE EXPECTED AND PLANNED SURGERY GOAL. IT IS VERY LIKELY THAT AN ADDITIONAL RE-OP (2ND SURGERY) WILL BE EXECUTED IN ORDER TO ACHIEVE THE PLANNED GOAL FOR THE PATIENT.
Patient problems: Visual Impairment
MAUDE report 23840374 ↗InjuryDec 18, 2025Incorrect, Inadequate or Imprecise Result or Readings; Misassembly During Maintenance/Repair; Incorrect, Inadequate or Imprecise Result or Readings; Misassembly During Maintenance/Repair
IT WAS REPORTED THAT A PATIENT IN IRELAND HAS HAD A RESULT OF -2 DIOPTERS SURGICAL OUTCOME FROM THE EXPECTED AND PLANNED SURGERY GOAL. IT IS VERY LIKELY THAT AN ADDITIONAL RE-OP (2ND SURGERY) WILL BE EXECUTED IN ORDER TO ACHIEVE THE PLANNED GOAL FOR THE PATIENT.
Patient problems: Visual Impairment
MAUDE report 23840145 ↗MalfunctionNov 10, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
A CUSTOMER FROM BRAZIL COMPLAINED ABOUT IOL (INTRAOCULAR LENS) CALCULATIONS ON AN IOLMASTER 700 HAVING A DISCREPANCY OF APPROXIMATELY 2 DIOPTERS COMPARED TO ANOTHER BRAND'S DEVICE. A ZEISS SERVICE TECHNICIAN WENT ONSITE AND DURING INVESTIGATION OF THE DEVICE, INCORRECT AXIAL LENGTH MEASUREMENTS WERE FOUND. THERE IS NO INFORMATION ABOUT ANY NEGATIVE IMPACT ON A PATIENT (LIKE LENS RE-IMPLANTATION). IT IS ALSO NOT KNOWN WHETHER THE MEASUREMENT DATA FROM THE IOLMASTER 700 WAS USED FOR ANY IOL CALCULATION AND SURGERY.
Patient problems: Insufficient Information
MAUDE report 23518874 ↗MalfunctionNov 4, 2025Incorrect, Inadequate or Imprecise Result or Readings; Low Readings; Misassembly During Maintenance/Repair; Incorrect, Inadequate or Imprecise Result or Readings; Low Readings; Misassembly During Maintenance/Repair
A ZEISS FIELD SERVICE ENGINEER (FSE) WAS PERFORMING A CMOS BATTERY REPLACEMENT ON AN IOL MASTER 700 AT A CUSTOMER SITE BECAUSE THE DEVICE WAS REPORTED TO NOT BE POWERING ON ANYMORE. DURING THE CHECKOUT, HE NOTICED A SIGNIFICANT DISCREPANCY IN THE AXIAL LENGTH MEASUREMENTS, WITH THE TEST EYE SHOWING 28.296 COMPARED TO THE REFERENCE VALUE OF 28.039, EXCEEDING THE ACCEPTABLE THRESHOLD OF 0.02. THE DEVICE HAD BECOME UNCALIBRATED. THE DEVICE WAS TAKEN OUT OF SERVICE UNTIL IT WAS REPAIRED AND BROUGHT BACK INTO ZEISS SPECIFICATIONS. THERE WAS NO NEGATIVE IMPACT ON A PATIENT (LIKE LENS RE-IMPLANTATION). CUSTOMER CONFIRMED THERE WERE NO RE-OPERATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23471140 ↗MalfunctionSep 9, 2025Incorrect, Inadequate or Imprecise Result or Readings; High Readings; Misassembly During Maintenance/Repair; Incorrect, Inadequate or Imprecise Result or Readings; High Readings; Misassembly During Maintenance/Repair
DURING A SYSTEM CHECKOUT BEING PERFORMED ON AN IOLMASTER 700 DEMONSTRATION DEVICE IN SOUTH AFRICA, A ZEISS FIELD SERVICE ENGINEER (FSE) FOUND THAT THE OCT LENGTH WAS OUT OF TOLERANCE. SECOND LEVEL SUPPORT WAS CONTACTED AND THE DEVICE WAS TAKEN OUT OF SERVICE. IT IS NOT KNOWN WHETHER THE DEVICE WAS BEING USED FOR MEASURING PATIENTS. THERE IS NO INFORMATION THAT INCORRECT MEASUREMENT VALUES WERE USED FOR THE CALCULATION AND IMPLANTATION OF INTRAOCULAR LENSES. THERE IS ALSO NO INFORMATION ABOUT ANY NEGATIVE IMPACT TO A PATIENT (LIKE LENS RE-IMPLANTATION).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23004430 ↗InjuryJun 4, 2025Use of Device Problem; Use of Device Problem
CUSTOMER REPORTED POST OP SURPRISE FOR THEIR PATIENT THAT HAD THE ALCON VIVITY LENS. THEREFORE, A RE-OP WAS PERFORMED.
Patient problems: Visual Impairment
MAUDE report 22144015 ↗InjuryJun 4, 2025Use of Device Problem; Use of Device Problem
CUSTOMER REPORTED POST OP SURPRISE FOR THEIR PATIENT THAT HAD THE ALCON VIVITY LENS. THEREFORE, A RE-OP LASIK WAS PERFORMED.
Patient problems: Visual Impairment
MAUDE report 22144014 ↗InjuryMar 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTH CARE PROFESSIONAL REPORTED MEASUREMENT DISCREPANCIES AND REFRACTIVE SURPRISE ON A PATIENT. THE DOCTOR WILL BE DOING IOL EXCHANGE TO CORRECT PATIENT'S VISION.
Patient problems: Visual Impairment
MAUDE report 21654404 ↗InjuryMar 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTH CARE PROFESSIONAL REPORTED MEASUREMENT DISCREPANCIES AND REFRACTIVE SURPRISE ON A PATIENT. THE DOCTOR IMPLANTED A SECOND IOL (PIGGYBACK) TO CORRECT PATIENT'S VISION.
Patient problems: Visual Impairment
MAUDE report 21654390 ↗InjuryMar 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTH CARE PROFESSIONAL REPORTED MEASUREMENT DISCREPANCIES AND REFRACTIVE SURPRISE ON A PATIENT. THE DOCTOR WILL BE DOING IOL EXCHANGE TO CORRECT PATIENT'S VISION.
Patient problems: Visual Impairment
MAUDE report 21654214 ↗InjuryMar 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTH CARE PROFESSIONAL REPORTED MEASUREMENT DISCREPANCIES AND REFRACTIVE SURPRISE ON A PATIENT. THE DOCTOR WILL BE DOING IOL EXCHANGE TO CORRECT PATIENT'S VISION.
Patient problems: Visual Impairment
MAUDE report 21654198 ↗MalfunctionNov 8, 2024Incorrect, Inadequate or Imprecise Result or Readings; High Readings; Calibration Problem; Incorrect, Inadequate or Imprecise Result or Readings; High Readings; Calibration Problem
CUSTOMER IN THAILAND REPORTED THAT THE IOLMASTER 700 SEEMS TO HAVE UNSTABLE VALUES. THE VALUES DID NOT MATCH THE VALUES TAKEN FROM OTHER HOSPITALS IN THE SAME PATIENT CASE. A DEMO MACHINE WAS BROUGHT IN BY ZEISS SERVICE TO COMPARE AND FOUND THAT THE CALCULATION RESULTS WERE DIFFERENT ABOUT 1 DIOPTER. THE MEASURED AXIAL LENGTH VALUE IS LONGER BY AN AVERAGE OF ABOUT 0.23-0.27 MM COMPARED TO THE DEMO UNIT AND OTHER UNITS IN THE HOSPITAL. THIS WILL CAUSE THE CALCULATION OF THE ARTIFICIAL LENS VALUE TO BE INCORRECT BY ABOUT 0.5-1.0 D. PATIENT DATA WAS REQUESTED. THERE IS NO INFORMATION ABOUT NEGATIVE IMPACT TO A PATIENT (LENS RE-IMPLANTATION).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20646149 ↗InjurySep 11, 2024Use of Device Problem; Use of Device Problem
THE CUSTOMER REPORTED THAT THE POST-OP REFRACTION WAS FOUND TO BE OFF. MEDICAL INTERVENTION WAS NEEDED TO ADDRESS THE ISSUE. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Visual Impairment
MAUDE report 20195051 ↗InjurySep 11, 2024Use of Device Problem; Use of Device Problem
THE CUSTOMER REPORTED THAT THE POST-OP REFRACTION WAS FOUND TO BE OFF. MEDICAL INTERVENTION WAS NEEDED TO ADDRESS THE ISSUE. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Visual Impairment
MAUDE report 20194405 ↗InjurySep 11, 2024Use of Device Problem; Use of Device Problem
THE CUSTOMER REPORTED THAT THE POST-OP REFRACTION WAS FOUND TO BE OFF. MEDICAL INTERVENTION WAS NEEDED TO ADDRESS THE ISSUE. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Visual Impairment
MAUDE report 20194295 ↗InjuryJul 12, 2024Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Use of Device Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A DOCTOR PERFORMED SURGERY WITH CLEAR LENS AND THE DEVIATION IN SURGERY RESULT WAS +1.5 DIOPTER. THE DOCTOR HAD TO EXCHANGE THE LENS TO CORRECT PATIENT'S VISION. THE DOCTOR COMMUNICATED THAT THE TEST EYE CHECK PASSED SUCCESSFULLY.
Patient problems: Visual Impairment
MAUDE report 19735308 ↗InjuryJul 12, 2024Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Use of Device Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A DOCTOR PERFORMED SURGERY WITH CLEAR LENS AND THE DEVIATION IN SURGERY RESULT WAS +1.5 DIOPTER. THE DOCTOR HAD TO EXCHANGE THE LENS TO CORRECT PATIENT'S VISION. THE DOCTOR COMMUNICATED THAT THE TEST EYE CHECK PASSED SUCCESSFULLY.
Patient problems: Visual Impairment
MAUDE report 19735265 ↗InjuryJun 7, 2024Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT THE PATIENT UNFORTUNATELY HAD A POOR OUTCOME. MEASUREMENTS ARE SIGNIFICANTLY DIFFERENT PRE AND POST OP. A LENS REPOSITIONING WAS PERFORMED.
Patient problems: Visual Impairment
MAUDE report 19484842 ↗
Other Biomicroscope, Slit-Lamp, Ac-Powered devices
- IOLMaster 500Carl Zeiss Meditec AG · Biomicroscope, Slit-Lamp, Ac-Powered1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page