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)
Date of Event	07/17/2017
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 explant of a tecnis toric intraocular lens (iol), model zct400 17.0 diopter, was performed due to refractive error.No additional information was provided.
Additional Manufacturer Narrative
(b)(6).If implanted, give date: (b)(6) 2017.(b)(6).Here was an unexplained refractive error.There were no complications such as an incision enlargement, vitrectomy, or capsule tear when removing the lens.The patient was doing well when discharged.The lens was replaced with a lens of different model and diopter.All pertinent information available to abbott medical optics has been submitted.
Additional Manufacturer Narrative
Device available for evaluation? yes, returned to manufacturer on 8/11/2017.Device returned to manufacturer? yes.Device evaluation: visual inspection with the unaided eye shows the product was cut in pieces, most probably to make explant possible.Considering the condition of the lens, additional analysis was not possible.The reported complaint was not 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.

• Brand Name: TECNIS
• Common Device Name: TORIC IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA 92705
• MDR Report Key: 6805900
• Report Number: 9614546-2017-00770
• Device Sequence Number: 1540608
• Product Code: HQL
• UDI-Device Identifier: 05050474553859
• UDI-Public: (01)05050474553859(17)180207
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 10/18/2017

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: 02/07/2018
• Device Model Number: ZCT400
• Device Catalogue Number: ZCT400U170
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2017
• Initial Date Received by Manufacturer: 07/25/2017
• Supplement Date Received by Manufacturer: 09/06/2017; 09/26/2017
• Initial Report FDA Received Date: 08/18/2017
• Supplement Report FDA Received Date: 09/29/2017; 10/19/2017
• 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