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

Model Number	ZCT150
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Codes	Capsular Bag Tear (2639); Vitrectomy (2643)
Date of Event	01/10/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Implant date: if implanted, give date: not applicable, as the lens was not fully implanted.Explant date: if explanted, give date: not applicable, as the lens was not implanted; therefore, not explanted.All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that a zct150 18.5 diopter intraocular lens was inserted in a male patient's right eye, but had to be removed due to the patient's capsule rupturing.Further clarification was provided that how the event occurred was that the lens unfolded, was implanted but the capsule tore.The physician is not sure but stated that the lens had a jagged edge, described as a piece of plastic or something on the lens that caused the capsule to tear/rupture.The lens was removed from the eye and a vitrectomy was required.The replacement lens was a non-amo device.There was no incision enlargement and no patient post-op injury.
Additional Manufacturer Narrative
Device available for evaluation ¿ yes, returned to manufacturer on 02/15/2017.Device returned to manufacturer ¿ yes.Device evaluation the device was returned to the manufacturer.Visual inspection with the unaided eye shows the product is cut in pieces, most probably to make remove and replacement possible.Considering the condition of the lens additional analysis is not possible.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.The directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the intraocular lenses.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: 6295401
• Report Number: 9614546-2017-00062
• Device Sequence Number: 1610628
• Product Code: HQL
• UDI-Device Identifier: 05050474552111
• UDI-Public: (01)05050474552111(17)201114
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2017

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?: Yes
• Operator of Device: Physician
• Device Expiration Date: 11/14/2020
• Device Model Number: ZCT150
• Device Catalogue Number: ZCT150U185
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/10/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/02/2017
• Supplement Report FDA Received Date: 04/17/2017
• 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: 67 YR