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 Codes	Discomfort (2330); No Code Available (3191)
Date of Event	04/10/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age/date of birth: unknown, not provided.Gender/sex: unknown/not provided.If implanted, give date: unknown / not provided.If explanted, give date: unknown / not provided.(b)(4).All pertinent information available to the manufacturer has been submitted.
Event or Problem Description
It was reported that patient was uncomfortable with lens that was implanted in right eye for near vision.Lens was explanted and replaced with one for far vision.
Additional Manufacturer Narrative
Additional information received reported the implant date was (b)(6) 2017 and the explant date was (b)(6) 2017.There was no incision enlargement, vitrectomy, or sutures used.The lens was replaced with a zct150 17.0 diopter intraocular lens (iol).Post-operatively, the patient is doing well.Also, the reason for explantation of the lens was because the patient wasn't happy with his outcome after the initial surgery.In addition, the surgeon's name was dr.(b)(6) and the patient was a (b)(6) year old male.No additional information was provided.Age/date of birth: (b)(6) years old.Gender/sex: male.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.All pertinent information available to abbott medical optics has been submitted.
Additional Manufacturer Narrative
Device available for evaluation?: yes, returned to manufacturer on 08/15/2017.Device returned to manufacturer?: yes.Device evaluation: the intraocular lens (iol) was returned to the manufacturing site for evaluation.Visual inspection with the unaided eye showed the product is cut in pieces, most probably to make explant possible.Considering the condition of the lens additional analysis is not possible.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.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
• MDR Report Key: 6751589
• Report Number: 9614546-2017-00676
• Device Sequence Number: 16357424
• Product Code: HQL
• UDI-Device Identifier: 05050474552135
• UDI-Public: (01)05050474552135(17)210301
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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): 12/14/2017

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: 03/01/2021
• Device Model Number: ZCT150
• Device Catalogue Number: ZCT150U195
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2017
• Initial Date Received by Manufacturer: 07/05/2017
• Supplement Date Received by Manufacturer: 09/11/2017; 11/15/2017
• Initial Report FDA Received Date: 07/28/2017
• Supplement Report FDA Received Date: 10/07/2017; 12/14/2017
• 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: 68 YR