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

Model Number	ZXT375
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	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 during 2017.(b)(4).An attempt has 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 a zxt375 31.5 diopter intraocular lens (iol) was implanted into the patient's operative eye.It was later explanted and replaced with a zxt375 28.5 diopter iol.No additional information was provided.
Additional Manufacturer Narrative
Device evaluation: the product testing could not be performed as the product was not returned.The reported complaint cannot be confirmed.Manufacturing record review: the manufacturing process record was evaluated and no deviation was found during process related to the complaint issue reported.There was no discrepancy found during the mrr (manufacturing record review).The product was manufactured and released according to the specifications.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.
Additional Manufacturer Narrative
Additional information received reported the implant date was (b)(6) 2017 and the explant date was (b)(6) 2017.The replacement lens was a zxt375 with serial number (b)(4).Also, the reason for explanting the lens was due to an unexpected post-operative refraction needing a diopter change.The doctor was dr.(b)(6), there was no patient injury, and no incision enlargement performed.The patient is a female with initials (b)(6), date of birth (b)(6), and operative eye being the right.No additional information was provided.Age/date of birth: (b)(6), gender/sex: female.If implanted, give date: (b)(6) 2017, if explanted, give date: (b)(6) 2017.Initial reporter name: dr.(b)(6), health professional: yes, occupation: physician.(b)(4).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: 7085222
• Report Number: 9614546-2017-01196
• Device Sequence Number: 19150655
• Product Code: POE
• UDI-Device Identifier: 05050474607200
• UDI-Public: (01)05050474607200(17)220224
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 05/03/2018

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: 02/24/2022
• Device Model Number: ZXT375
• Device Catalogue Number: ZXT375U315
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/07/2017
• Supplement Date Received by Manufacturer: 03/05/2018; 04/06/2018
• Initial Report FDA Received Date: 12/05/2017
• Supplement Report FDA Received Date: 03/30/2018; 05/03/2018
• 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