MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS IDESIGN AWS SYSTEM; REFRACTIVE MEASUREMENT

Model Number 0110-0001

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Visual Impairment (2138); No Code Available (3191)

Event Date 10/19/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Fse on site completed the following: viewed all technicians that utilized the idesign during the capture sequence.Completed idesign clinical optimization checklist.Asm discussed outcomes with the tlc account regional director, clinic director and the physician.It was found that found that physician planned all treatments and the nomogram used was gleaned from a different tlc site in (b)(6).Two other physicians mentioned that the physician reporting the issues comes in (to the center) and steps into the footpedal.All pertinent information available to abbott medical optics has been submitted.

Event Description

The clinic reported that a laser vision correction patient had surgery on (b)(6) 2017 and presented on 1 month post-op with an astigmatism in both eyes.It was stated that the patient had a loss of best corrected visual acuity (bcva).Bcva: right eye pre-op 20/20 -6.25 x.00 x 0, left eye pre-op 20/20 -6.00 x.00 x 0.Bcva 1 month post-op: right eye post-op 20/30 -.25 x -.50 x 157, left eye post-op 20/30.00 x -.50 x 12.This report is for the idesign aberrometer.A separate report is being submitted for the excimer laser.

Manufacturer Narrative

Initially reported device manufacturing date from 11/1/2016 to corrected device manufacturing date august 2016.Device evaluation: a review of the records related to the device that included labeling, manuals, trending, and risk documentation was performed.The trend review shows that there is not significant change over historical complaint limits and no recognizable adverse trend.The risks and mitigations associated with the complaint issue are identified in existing risk documents and no new risks were identified as part of this investigation.There was no product deficiency identified.The review of the device history record (dhr) the refractive idesign showed that there were no issues or non-conformities.Manufacturing has been ruled out as a potential cause for the reported issue.No conclusive evidence identified for reported issue.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: IDESIGN AWS SYSTEM
• 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: 7250162
• MDR Text Key: 99295094
• Report Number: 3006695864-2018-00233
• Device Sequence Number: 1
• Product Code: HKO
• UDI-Device Identifier: 05050474573437
• UDI-Public: (01)05050474573437
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K000327
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 0110-0001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2016
• 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: 52 YR