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

Model Number	ZCT600
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/09/2017
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 a zct600 27.0 diopter intraocular lens was implanted into the patients right eye (od) on (b)(6) 2016.It was later explanted on (b)(6) 2017 and replaced with the same model, but different diopter (23.5).No additional information was provided.
Additional Manufacturer Narrative
Device evaluation: the product testing could not be performed because the product was not returned for evaluation.Device inspection could not be performed, therefore the reported complaint could not be confirmed.Manufacturing record review: manufacturing records were reviewed and the device was manufactured according to specification.A search on complaints revealed no similar complaints were received for this production order number to date.Conclusion: based on the investigation results there is no indication of a product quality deficiency.All pertinent information available to the manufacturer has been submitted.

• Brand Name: TECNIS
• Common Device Name: TORIC IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA 92705
• MDR Report Key: 6860852
• Report Number: 9614546-2017-00869
• Device Sequence Number: 565986
• Product Code: HQL
• UDI-Device Identifier: 05050474604308
• UDI-Public: (01)05050474604308(17)210411
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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): 10/20/2017

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: 04/11/2021
• Device Model Number: ZCT600
• Device Catalogue Number: ZCT600U270
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/21/2017
• Supplement Date Received by Manufacturer: 09/25/2017
• Initial Report FDA Received Date: 09/12/2017
• Supplement Report FDA Received Date: 10/20/2017
• 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: 58 YR