MAUDE Adverse Event Report: WAVELIGHT GMBH (AGPS) VERION REFERENCE UNIT; KERATOMETER, PUPILLOMETER

Model Number X-RUS

Device Problem Application Program Problem: Power Calculation Error (1473)

Patient Problem Therapeutic Response, Decreased (2271)

Event Type  malfunction  

Manufacturer Narrative

Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.Several attempts were made to obtain further information on the event with no response to date.(b)(4).

Event Description

A nurse reported that the surgeon was dissatisfied with the intraocular lens (iol) calculations given by the system software.The patient had three diopters of astigmatism prior to the surgery.Following the iol implant surgery, the patient still had one and a half diopters of residual astigmatism.According to the nurse, the patient had previously undergone lasik surgery, many years ago, and this made it difficult to measure the patient for the iol calculations.Several attempts were made to obtain further information on the event with no response to date.

Manufacturer Narrative

Evaluation summary: sample was not returned.Provided documentation has been investigated.Preoperative measurements using verion reference unit assume a regular cornea of the patient¿s eye.The provided information of the event described that a surgery was planned and performed for a patient with an irregular cornea due to a previous performed lasik surgery.Under the given conditions a cross check with alternative diagnostic devices/methods is recommended according to the user manual.For post lasik cases specific intraocular lens (iol) calculation methods or formulas should have been used to provide the appropriate iol power.¿alternate-k¿ function is available in case previous lasik was selected as pre-existing condition to calculate the alternate k-readings that should be used for appropriate post lasik iol calculation.No technical root cause could be determined, based on the information provided.

Manufacturer Narrative

Evaluation summary: sample was not returned.Provided documentation has been investigated.No technical root cause could be determined, based on the information provided.Preop measurements using the product assume a regular cornea of the patient¿s eye.The provided information of the event describes that a surgery was planned and performed for a patient with an irregular cornea due to a previous performed lasik surgery.For post lasik cases specific iol calculation methods or formulas should be used to provide the appropriate iol power.The ¿alternate-k¿ function is available for these cases.With provided information, it could not be determined, which formula has been used.A malfunction of the device could not be determined.The manufacturer internal reference number is: 2015-133833.

• Brand Name: VERION REFERENCE UNIT
• Type of Device: KERATOMETER, PUPILLOMETER
• Manufacturer (Section D): WAVELIGHT GMBH (AGPS); rheinstrasse 8; telow berlin 14513 ; GM 14513
• Manufacturer (Section G): WAVELIGHT GMBH (AGPS); rheinstrasse 8; telow berlin 14513 ; GM 14513
• Manufacturer Contact: eddie darton, md, jd ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175686660
• MDR Report Key: 5313354
• MDR Text Key: 34739954
• Report Number: 3010300699-2015-00521
• Device Sequence Number: 1
• Product Code: HLG
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: X-RUS
• Device Catalogue Number: 8065998240
• Device Lot Number: ASKU
• Other Device ID Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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