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

Model Number	ZCT400
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
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).All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that a zct400 14.5 diopter intraocular lens (iol) was explanted from the patient's operative eye because of a very strong refractive surprise and the patient needed a stronger powered lens.No additional information was provided.
Additional Manufacturer Narrative
Additional information received reported that there was no visual issues and just a refractive surprise.There was no incision enlargement, vitrectomy, or capsule tear.Reportedly, the patient is doing well post-operatively.Also, the doctor's name was dr.Christopher lin, the implant date was (b)(6) 2017, and the explant date was (b)(6) 2017.No additional information was provided.If implanted, give date: (b)(6) 2017.If explanted, give date: (b)(6) 2017.Device available for evaluation: yes returned to manufacturer on: 11/24/2017.Device returned to manufacturer: yes.Initial reporter name: dr.(b)(6).Health professional: yes.Occupation: physician.Device evaluation: the product was returned to the manufacturing site for evaluation.Visual inspection with the unaided eye shows the product is damaged and incomplete, most probably to make explant possible.Considering the condition of the lens additional analysis is not possible.The customer's reported event could not be confirmed.Manufacturing records review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.A search on complaints revealed that no similar complaints were received for this production order number.Labeling review: the directions for use (dfu) was reviewed.The 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
• Common Device Name: TORIC IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA 92705
• MDR Report Key: 7062102
• Report Number: 9614546-2017-01167
• Device Sequence Number: 1916144
• Product Code: HQL
• UDI-Device Identifier: 05050474553804
• UDI-Public: (01)05050474553804(17)180314
• 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
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2018

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: 03/14/2018
• Device Model Number: ZCT400
• Device Catalogue Number: ZCT400U145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2017
• Initial Date Received by Manufacturer: 10/30/2017
• Supplement Date Received by Manufacturer: 01/02/2018
• Initial Report FDA Received Date: 11/27/2017
• Supplement Report FDA Received Date: 01/26/2018
• 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