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

Model Number	ZCT150
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
(b)(4).All pertinent information available to the manufacturer has been submitted.
Event or Problem Description
It was reported that a zct150 13.5 diopter intraocular lens (iol) was explanted due to patient wanting a symfony lens instead of a monofocal lens.The lens was replaced with zxt150 iol with the same diopter size.Incision was enlarged by 3mm during procedure.No suture was required and there was no patient injury reported.
Additional Manufacturer Narrative
Corrected data: the initial mdr the date (b)(6) 2017 was entered as the explant date.However through follow up it was learned that this date was not the explant date but is the implant date.If implanted, give date - has been now been populated with (b)(6) 2017.Additional information was received and it was learned that the lens was implanted on (b)(6) 2017.It was also learned that the patient did not experience any visual issues.When discharged, patient was in good condition and no injuries were reported.In addition patient information and the physician's name was provided.Age/date of birth: (b)(6).Gender/sex: male.If implanted, give date: (b)(6) 2017.Initial reporter - dr.(b)(6).Health professional - yes.Occupation - physician.Device evaluation: the device was not returned to the manufacturer for evaluation.Device inspection could not be performed, therefore the reported issue could not be verified.Manufacturing records were reviewed and the lens was manufactured according to specification.A search on complaints revealed that no similar complaints were received for this production order number.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
• MDR Report Key: 6672532
• Report Number: 9614546-2017-00572
• Device Sequence Number: 72162
• Product Code: HQL
• UDI-Device Identifier: 05050474552012
• UDI-Public: (01)05050474552012(17)181110
• 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
• Report Date (Section B): 07/25/2017

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: 11/10/2018
• Device Model Number: ZCT150
• Device Catalogue Number: ZCT150U135
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/06/2017
• Supplement Date Received by Manufacturer: 06/30/2017
• Initial Report FDA Received Date: 06/28/2017
• Supplement Report FDA Received Date: 07/25/2017
• 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