MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS TECNIS SYMFONY TORIC; MULTIFOCAL IOLS

Model Number	ZXT225
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Blurred Vision (2137); No Code Available (3191)
Date of Event	09/20/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that patient underwent intraocular lens implant in his right eye and was experiencing unexpected post op refraction.The lens was explanted.Post op day one, distance visual acuity 20/30, j3 near vision.Post up week one, distance visual acuity 20/40, j7 near vision.Post op week three, distance visual acuity 20/40, blurry, slow to read, -1.00 + 1.25 x 121, no near refraction was performed.The symptoms have been noted to be interfering with the activities of daily life for the patient.The lens was replaced with a zcb00 15.5 iol lens.No further information was provided.
Additional Manufacturer Narrative
Corrected data: on the initially received medical device complaint reporting form in the field for other medical related; describe: possible surface issues was noted.This information was inadvertently left out of the initial filing.No further information could be obtain to clarify this issue.(b)(4).All pertinent information available to abbott medical optics has been submitted.
Additional Manufacturer Narrative
Device evaluation: the device was not returned to the manufacturer for evaluation.Device inspection could not be performed, therefore the reported complaint could not be verified.Manufacturing records were reviewed and the lens was manufactured according to specification.A search on complaints revealed no similar complaints were received for this production order number.The directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the intraocular lenses.Based on the investigation results there is no indication of a product quality deficiency.All pertinent information available to the manufacturer has been submitted.

• Brand Name: TECNIS SYMFONY TORIC
• Common Device Name: MULTIFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6097047
• Report Number: 9614546-2016-00595
• Device Sequence Number: 1124043
• Product Code: POE
• UDI-Device Identifier: 05050474605695
• UDI-Public: (01)05050474605695(17)210725
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Physician
• Device Expiration Date: 07/25/2021
• Device Model Number: ZXT225
• Device Catalogue Number: ZXT225U150
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/17/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 11/11/2016
• Supplement Report FDA Received Date: 11/29/2016; 04/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR