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	No Consequences Or Impact To Patient (2199); No Code Available (3191)
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 a toric intraocular lens (iol) was explanted in a secondary surgical procedure, from the left eye of a female patient.Additional information was received and it was learnt that the lens was explanted because of a refractive surprise.No incision enlargement, no vitrectomy was performed, no sutures were used and no patient post-op injury was reported.No further information was provided.
Additional Manufacturer Narrative
Corrected data: additional information was received and it was learnt that the lens zct150 +20.5 diopter with serial number (b)(4), initially reported as explanted, was instead the replacement lens.The explanted lens is the zct150 +25.0 diopter with serial number (b)(4) already reported in the mdr report 9614546-2017-00002.No issues were reported for the lens (b)(4) and to date it remains implanted in the patent's' eye.Serial #: (b)(4), catalog #: zct150u250, expiration date: 6/15/2020, udi #: (b)(4).Manufacturing date: 6/15/2016.(b)(4).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: 6793481
• Report Number: 9614546-2017-00741
• Device Sequence Number: 16294733
• Product Code: HQL
• UDI-Device Identifier: 05050474552159
• UDI-Public: (01)05050474552159(17)200616
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2017

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: 06/15/2020
• Device Model Number: ZCT150
• Device Catalogue Number: ZCT150U250
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/20/2017
• Supplement Date Received by Manufacturer: 08/22/2017
• Initial Report FDA Received Date: 08/14/2017
• Supplement Report FDA Received Date: 09/13/2017
• 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