MAUDE Adverse Event Report: CARL ZEISS MEDITEC AG IOLMASTER 500; BIOMICROSCOPE, SLIT-LAMP, AC-POWERED

Model Number IOLMASTER 500

Device Problems Use of Incorrect Control/Treatment Settings (1126); Tidal Volume Fluctuations (1634)

Patient Problem No Code Available (3191)

Event Date 05/01/2014

Event Type  Injury  

Event Description

The customer reported that a technician had selected the wrong surgeon's name in the iol calculation screen in the iolmaster 500.The operating surgeon did not notice that the printout reflected another surgeon's ac lens in his preferred lens column.As a result, the operating surgeon chose the wrong lens power for his patient.The patient's pre-operative visual acuity: 20/40 best corrected and 20/60 (with glare testing) uncorrected.The patient's post-operative visual acuity: 20/20 best corrected and 20/25 +2 uncorrected.The patient's stable post-operative refraction: +2.25 ds.The operating surgeon performed a follow-up surgery to explant the unintended iol and implant the intended iol.

Manufacturer Narrative

This report was previously submitted in error on (b)(4) 2014 as medwatch mfr.Report no.9615010-2014-00011.Narrative: a field service engineer (fse) performed an on-site examination of the iolmaster 500.All parameters that influence measurement were within specification.Two parameters which do not influence these measurements were out of specification and adjusted to within specification.The manufacturer reviewed the iol calculation printout and found the calculations performed by the iolmaster 500 were correct.When the iolmaster 500 is used by a number of different surgeons, it is recommended to create surgeon specific records in the lens manager.The use of the lens manager is described in the software use manual on page 21 and 22.The site reported that they have implemented a cross-checking protocol in their workflow to safeguard against recurrent of the reported user error problem.Site contact: (b)(6) same address as initial reporter), (b)(6).

• Brand Name: IOLMASTER 500
• Type of Device: BIOMICROSCOPE, SLIT-LAMP, AC-POWERED
• Manufacturer (Section D): CARL ZEISS MEDITEC AG; jena ; GM
• Manufacturer (Section G): CARL ZEISS MEDITEC AG; carl zeiss promenade 10; jena ; GM
• Manufacturer Contact: judy brimacombe ; hacienda drive; dublin, CA 94568 ; 9255574616
• MDR Report Key: 3987640
• MDR Text Key: 4755117
• Report Number: 9615030-2014-00002
• Device Sequence Number: 1
• Product Code: HJO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122418
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date: 07/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: IOLMASTER 500
• Device Catalogue Number: 266002-1141-139
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/20/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2014
• 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): Other
• Patient Age: 71 YR
• Patient Weight: 92