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	Capsular Bag Tear (2639); Vitrectomy (2643); No Code Available (3191)
Date of Event	11/15/2017
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 after a zct150 19.5 diopter intraocular lens (iol) was implanted in the patient's left eye, the capsular bag and lens dropped to the bottom of the eye.The patient was referred to a retina specialist, who had to fish out the lens in a secondary procedure, date unknown.The lens was reportedly replaced with a sulcus lens.Reportedly, the patient's zonules were weak.Patient was reported to be post vitrectomy.No additional information was provided.
Additional Manufacturer Narrative
Additional information received reported the lens explant date was (b)(6) 2017.The patient had the original lens implanted at another facility and the implant date is not known.The patient had a vitrectomy done on (b)(6) 2017.The patient is doing fine after this procedure and did not have to come in for a follow up exam.No additional information was provided.The following sections have been updated accordingly: if implanted; give date: unknown, was not provided.If explanted; give date: (b)(6) 2017.(b)(4).Device evaluation: the product was not returned to the manufacturing site.Therefore, product testing could not be performed and the customer¿s reported complaint could not be verified.Manufacturing records review: the manufacturing records for the product was reviewed.The product was manufactured and released according to specification.A search on complaints revealed that no similar complaints have been 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: 7123549
• Report Number: 9614546-2017-01232
• Device Sequence Number: 16483450
• Product Code: HQL
• UDI-Device Identifier: 05050474552135
• UDI-Public: (01)05050474552135(17)200502
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2018

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: 05/02/2020
• Device Model Number: ZCT150
• Device Catalogue Number: ZCT150U195
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/16/2017
• Supplement Date Received by Manufacturer: 12/11/2017
• Initial Report FDA Received Date: 12/15/2017
• Supplement Report FDA Received Date: 01/09/2018
• 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
• Patient Age: 65 YR