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

Model Number X-RUS

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Postoperative refraction, unexpected (2642)

Event Date 05/12/2014

Event Type  Injury  

Event Description

A technician reported that following an intraocular lens (iol) implant procedure, a patient experienced an unexpected refractive outcome in the left eye.The lens was exchanged six weeks later for the same model lens, 1.5 diopters difference in power.In a follow up, the surgeon reported that the system took inaccurate corneal measurements, which caused the incorrect iol power to be selected initially.The surgeon targeted for an outcome of -2.00 for monovision, but the patient ended up with -3.25.The event resolve with the iol exchange.No further information is expected.

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.(b)(4).

• Brand Name: REFERENCE UNIT
• Type of Device: KERATOMETER, PUPILLOMETER
• Manufacturer (Section D): WAVELIGHT GMBH AGPS; am wolfsmantel 5; erlangen 91058 ; GM 91058
• Manufacturer (Section G): WAVELIGHT GMBH (AGPS); am wolfsmantel 5; erlangen 9105 8; GM 91058
• Manufacturer Contact: janet moran ; 6201 south freeway, r3-48; fort worth, TX 76134 ; 8176152742
• MDR Report Key: 4620851
• MDR Text Key: 19603187
• Report Number: 3010300699-2014-00006
• Device Sequence Number: 1
• Product Code: HJB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: X-RUS
• Device Catalogue Number: 8065998240
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/03/2014
• 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
• Treatment: DISCOVISC; MONARCH D CARTRIDGE; AUTOSERT HANDPIECE; LENSX; SN60WF IOL; ZYLET 0.3-0.5%; ORA
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR