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); No Code Available (3191)
Date of Event	01/20/2017
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 initially reported that a model zct150 19.5 diopter lens was explanted from a male patient¿s left eye.The patient had prior surgery post capsular rupture, poor visual acuity and a non amo sulcus lens was implanted.Through follow up it was clarified that the doctor realized that the patient had a posterior capsule tear from a prior surgery; therefore, the patient would need to have another type of lens and not the zct150.The doctor implanted the lens (zct150) on (b)(6) 2017 and it was explanted on (b)(6) 2017.There was incision enlargement and two (2) sutures were placed.The contact confirmed that there was no vitrectomy required and no patient injury.The contact could not provide anything further regarding the poor visual acuity that was initially reported and did not know the patient outcome.No further information provided.
Additional Manufacturer Narrative
Additional information: device available for evaluation? yes, returned to manufacturer on: 4/7/2017, device returned to manufacturer? yes.Device evaluation: the intraocular lens (iol) was returned to the manufacturer.Visual inspection of the return sample shows the product is cut in pieces, most probably to make explant possible.Considering the condition of the lens additional analysis is not possible.The complaint cannot be confirmed.Manufacturing record review: manufacturing records were reviewed and the device was manufactured according to specification.A search on complaints history revealed no similar complaints were received for this product order number to date.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the product.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
• MDR Report Key: 6363443
• Report Number: 9614546-2017-00145
• Device Sequence Number: 18967804
• Product Code: HQL
• UDI-Device Identifier: 05050474552135
• UDI-Public: (01)05050474552135(17)181118
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2017

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: 11/18/2018
• Device Model Number: ZCT150
• Device Catalogue Number: ZCT150U195
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/01/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/28/2017
• Supplement Report FDA Received Date: 06/13/2017
• 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: 72 YR