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	Corneal Edema (1791); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown, not provided; best estimate october 10 to october 22, 2017.(b)(4).All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that a zxt225 18.5 diopter intraocular lens (iol) was implanted in the left eye (os) on (b)(6) 2017.Post-operatively, the patient's refraction was +0.50 x +0.75.It was later explanted on (b)(6) 2017 due to a refractive surprise.Reportedly, the lens was cut in half and removed.There was no extension of the incision since the lens was cut in half to remove, but a suture was used.Post-operatively, on (b)(6) 2017, the doctor reported the patient as having some edema, so the vision is not optimal.The lens was replaced with the same model, but different diopter of 19.5.Reportedly, the patient had a follow up scheduled to see the doctor on (b)(6) 2017.The patient is happy and seeing better with a visual acuity of 20/50 and j5, which the doctor reported as being because of residual astigmatism from the suture.No additional 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 at 12x magnification was performed.Product was cut in twice mostly probably to make explant possible.Considering the condition of the returned device additional analysis is not possible.The reported 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 from 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.

• Brand Name: TECNIS SYMFONY TORIC
• Common Device Name: MULTIFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA 92705
• MDR Report Key: 7060702
• Report Number: 9614546-2017-01163
• Device Sequence Number: 16388129
• Product Code: POE
• UDI-Device Identifier: 05050474605763
• UDI-Public: (01)05050474605763(17)220612
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Report Date (Section B): 03/08/2018

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: 06/12/2022
• Device Model Number: ZXT225
• Device Catalogue Number: ZXT225U185
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2018
• Initial Date Received by Manufacturer: 10/20/2017
• Supplement Date Received by Manufacturer: 02/09/2018
• Initial Report FDA Received Date: 11/27/2017
• Supplement Report FDA Received Date: 03/09/2018
• 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: 65 YR