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

Model Number	ZXT150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Glaucoma (1875); Halo (2227); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown, not provided, but the best estimate date is approximately between (b)(6) 2017.If explanted, give date: not applicable, as the lens remains implanted.However, there is a planned explant scheduled for (b)(6) 2018.(b)(4).All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that a zxt150 8.0 diopter intraocular lens (iol) was implanted in the patient's left eye (os) on (b)(6) 2017.There is a planned explant scheduled for (b)(6) 2018, to exchange the lens for a monofocal lens because the patient was unhappy with the lens implantation post-operatively, including complaints of seeing multiple circles from lights at night.Reportedly, there was no patient injury and the only contributing factor related to the patient's visual acuity issues is glaucoma.The patient has a normal retina and visual acuity was 20/20.The patient's symptoms have been monitored for 10-12 weeks post-operatively without resolution.No additional information was provided.
Additional Manufacturer Narrative
Device evaluation: the product testing was not performed as the complaint device was not returned for analysis; the intraocular lens remains implanted.The reported complaint cannot be confirmed.Manufacturing record review: manufacturing records were reviewed and the device was manufactured according to specification.A search on complaints history revealed no similar complaints were received for this production order number to date.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.

• Brand Name: TECNIS SYMFONY TORIC
• Common Device Name: MULTIFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA 92705
• MDR Report Key: 7159147
• Report Number: 9614546-2018-00003
• Device Sequence Number: 100373
• Product Code: POE
• UDI-Device Identifier: 05050474604964
• UDI-Public: (01)05050474604964(17)220421
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2018

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: 04/21/2022
• Device Model Number: ZXT150
• Device Catalogue Number: ZXT150U080
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/04/2017
• Supplement Date Received by Manufacturer: 04/09/2018
• Initial Report FDA Received Date: 01/02/2018
• Supplement Report FDA Received Date: 04/27/2018
• 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