MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS WAVESCAN WS1; REFRACTIVE MEASUREMENT

Model Number 0070-0150

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 05/22/2015

Event Type  Injury  

Event Description

Account reported that patient had a decentered ablation with induced cylinder and that as a result the patient required a retreatment procedure (enhancement) post op.Patient history: pre-op manifest refraction on (b)(6) 2014.Right eye +4.50 -0.50 x 040 bcva 20/20.Left eye +3.50 -0.50 x 050 bcva 20/20.Patient lasik treatment was (b)(6) 2014.Desired correction: right eye: +3.30 -0.56 x 101.Left eye: +3.53 -0.67 x 051.Post op visit for (b)(6) 2015 bcva.Right eye +0.25 -1.00 x 010 bcva 20/20.Left eye 0.00 - 1.25 x 175 bcva 20/20.Patient had a conventional lasik enhancement in both eyes on (b)(6) 2015.Surgeon requested to have field service check out both systems, the wavescan and star excimer (b)(4).This is 2 of 2 reports.

Manufacturer Narrative

(b)(4).Mfg date requested but not available at the time of this report.Application support manager (asm) discussed with surgeon that wavescan refraction sphere will be 0.50 diopter less when compared to manifest refraction sphere due to monochromatic aberrations unless patient is accommodating.Plastics dated (b)(6)-2015 and (b)(6)-2015 were checked and found with no artifacts.Customer did not have plastic for (b)(6)-2014.Wavescan daily calibration performed by the asm was found within specifications and a system checked by field service engineer (fse) found system within specifications.All pertinent information available to abbott medical optics has been submitted.Placeholder.

Manufacturer Narrative

Initial report had typographical errors in patient¿s right eye pre-op manifest refraction from (b)(6) 2014.The correct reading should be +3.25 -0.50 x 100 bcva 20/20.

• Brand Name: WAVESCAN WS1
• Type of Device: REFRACTIVE MEASUREMENT
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• Manufacturer (Section G): ABBOTT MEDICAL OPTICS INC.; 510 cottonwood drive; milpitas CA 95035
• Manufacturer Contact: valerie sedzicki ; 1700 east st. andrew place; santa ana, CA 92705 ; 7142478567
• MDR Report Key: 4855048
• MDR Text Key: 5805844
• Report Number: 3006695864-2015-00303
• Device Sequence Number: 1
• Product Code: HKO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K000327
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,health professional,use
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 0070-0150
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/23/2015
• 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): Required Intervention
• Patient Age: 39 YR