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	Halo (2227); No Code Available (3191)
Date of Event	05/15/2017
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 an intraocular lens (iol) was explanted from the right eye of a (b)(6) male patient, because the patient was not happy with their vision.Additional information was received and it was learnt that the patient had excellent distance vision and good near vision.However he was experiencing halos and glare during the day and at night time.Reportedly, the symptoms did not improve with a trial of pilocarpine 1% drops.The patient was reported as still recovering from the lens exchange.No further information was provided.
Additional Manufacturer Narrative
Additional information was received an it was learnt that the patient was immensely troubled by bright light issues, night time worse than day time.The patient was mostly pleased with the distance vision clarity and moderately pleased with the near vision capability, but these benefits did not outweigh the negative visual experience.Reportedly, these potential issues were discussed with the patient before surgery.When the intraocular lens was explanted, there was no incision enlargement, no vitrectomy was performed and one suture was used.No patient injury post-op was reported.No further information was provided.(b)(6).All pertinent information available to abbott medical optics has been submitted.
Additional Manufacturer Narrative
Device available for evaluation? yes.Returned to manufacturer on: 07/13/2017.Device returned to manufacturer? yes.Device evaluation: the intraocular lens (iol) was returned at the manufacturing site for evaluation.Visual inspection at 12x microscope magnification showed that the optic surface was contaminated.The surface was cleaned using a swab, liquinox and water.After cleaning no anomalies were found on the lens.The customer's reported complaint could not be verified.Manufacturing records review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.A search revealed that no similar complaints for this order number have been received.Labeling review: the directions for use (dfu) were reviewed.The directions for use (dfu) adequately provides instructions and precautions along with warnings for the proper use and handling of the device.As a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.All pertinent information available to abbott medical optics 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: 6629970
• Report Number: 9614546-2017-00515
• Device Sequence Number: 13733831
• Product Code: POE
• UDI-Device Identifier: 05050474605091
• UDI-Public: (01)05050474605091(17)211125
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/21/2017

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: 11/25/2021
• Device Model Number: ZXT150
• Device Catalogue Number: ZXT150U145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2017
• Initial Date Received by Manufacturer: 05/17/2017
• Supplement Date Received by Manufacturer: Not provided; 07/27/2017
• Initial Report FDA Received Date: 06/09/2017
• Supplement Report FDA Received Date: 06/16/2017; 08/21/2017
• 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: 62 YR