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

Catalog Number 000000-1322-734

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Visual Impairment (2138)

Event Date 12/02/2021

Event Type  Injury  

Event Description

The following adverse event was reported by a hospital to mhra / uk: the patient's eye was measured for a lens using the iolmaster xp.In the right eye the result was excellent but the left eye's vision after the lens implant was not as good.When the biometry was repeated on the left eye, the results showed a different lens would give better vision.This is extremely unusual and can only be attributed to a fault with the measurement of the machine.The machine has been taken out of service.The machine is apparently obsolete for parts but safe to use.It is checked annually by zeiss.The last service report is from (b)(6) 2022.The machine has been taken out of use.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Device inspection was performed by zeiss field service engineer (fse) on (b)(6) 2022.To sum up, there were deviations noted in the checkout protocol.However, these have no influence on the accuracy of the measurement values.There is no indication that a malfunction of the iolmaster xp contributed to the surgical outcomes.The device was regularly serviced, and no safety or functional deficiencies were detected.The customer was contacted several times in order to receive further patient data.The customer did not respond, and did not provide any further data.Corrected data: h6: medical device problem code was changed from 3190 (insufficient information) to 2993 (adverse event without identified device or use problem); the code 10 (type of investigation) was added; investigation findings was changed from 3233 (results pending completion of investigation) to 213 (no device problem found); investigation conclusions was changed from 11 (conclusion not available yet) to 67 (no problem detected).

• Brand Name: IOLMASTER XP
• Type of Device: BIOMICROSCOPE, SLIT-LAMP, AC-POWERED
• Manufacturer (Section D): CARL ZEISS MEDITEC AG (JENA); carl zeiss promenade 10; jena, thueringia 07745 ; GM 07745
• Manufacturer (Section G): CARL ZEISS MEDITEC AG (JENA); carl zeiss promenade 10; jena, thueringia 07745 ; GM 07745
• Manufacturer Contact: manjaya hegde ; 5300 central parkway; dublin, CA 94568 ; 9252164697
• MDR Report Key: 15218535
• MDR Text Key: 297800993
• Report Number: 9615030-2022-00006
• Device Sequence Number: 1
• Product Code: HJO
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K993357
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 000000-1322-734
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/05/2008
• 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): Required Intervention