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

Model Number	ZCT400
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Visual Disturbances (2140); No Code Available (3191)
Date of Event	08/29/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown, not provided, but the best estimate date is between (b)(6) 2017.(b)(4).Attempts have been made to obtain missing information; however, to date, no response has been received.All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that tecnis toric intraocular lens (model zct400, +21.5 diopter) was explanted in secondary surgery because of the patient complaining of dysphotopsia.No further information was provided.
Additional Manufacturer Narrative
Device available for evaluation? yes.Returned to manufacturer on: 01/02/2018.Device returned to manufacturer? yes.Device evaluation: the sample was returned to the manufacturer.Visual inspection was performed and the product was cut in half, most probably to make the explant possible.Considering the condition of the lens, further analysis was not possible.The complaint cannot be confirmed.Manufacturing record review: manufacturing record review of the production order and related document revealed that the product was manufactured and released according to specification.There was no discrepancy found during the review.A search revealed that no similar complaints were received for this production order.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the product.Conclusion: based on the investigation results there is no indication of a product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: further information was provided and reported that since iol exchange, vision is better with this lens, i do not see the spots.Dysphotopsia was described as ''dirty vision like looking through dirty sink water'' and ''spots that move with eye''.Patient complained bitterly starting immediately after cataract surgery on (b)(6) 2017, with the lens which was well centered in the bag and on axis.Iol exchange performed on (b)(6) 2017, just short of three months since original surgery os, left eye.Visual acuity pre-operatively? -3.0 +3.5 x 180 20/25 glare 20/400, visual acuity post-operatively? -1.25 20/60.Date of birth: (b)(6), gender/sex: female.Date of event: (b)(6) 2017.(b)(6), health professional: yes, occupation: physician.(b)(4).All pertinent information available to abbott medical optics has been submitted.

• Brand Name: TECNIS
• Common Device Name: TORIC IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 7115305
• Report Number: 9614546-2017-01225
• Device Sequence Number: 1895720
• Product Code: HQL
• UDI-Device Identifier: 05050474553941
• UDI-Public: (01)05050474553941(17)191021
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/26/2018

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: 10/21/2019
• Device Model Number: ZCT400
• Device Catalogue Number: ZCT400U215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2018
• Initial Date Received by Manufacturer: 11/15/2017
• Supplement Date Received by Manufacturer: 01/25/2018; 02/26/2018
• Initial Report FDA Received Date: 12/13/2017
• Supplement Report FDA Received Date: 02/22/2018; 03/26/2018
• 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: 68 YR