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

Model Number	ZXT225
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes	Visual Disturbances (2140); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown, not provided.(b)(4).Device evaluation: the product was not returned for investigation and product testing could not be performed.The reported complaint could not be verified.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.A search revealed that no similar complaints for this order number have been received.Labeling review: the directions for use (dfu) were reviewed.The dfu provide the customer with proper usage instructions and guidelines.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.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.The patient was -2.00 +2.00 x 153.The doctor was going for a bit more myopia because the patient was having some difficulty with reading in her first eye, so he aimed for -0.5.The iol was replaced with an iol of the same model but different diopter.There were no complications during the iol exchange.When discharged, the patient was doing well and was stable.No additional information was provided to abbott medical optics.

• Brand Name: TECNIS SYMFONY TORIC
• Common Device Name: MULTIFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6787052
• Report Number: 9614546-2017-00726
• Device Sequence Number: 13916526
• Product Code: POE
• UDI-Device Identifier: 05050474605671
• UDI-Public: (01)05050474605671(17)210626
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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
• Report Date (Section B): 08/10/2017

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: 06/26/2021
• Device Model Number: ZXT225
• Device Catalogue Number: ZXT225U140
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2017
• Initial Report FDA Received Date: 08/10/2017
• 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: 60 YR