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

Model Number	ZCT300
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/27/2016
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 (+18.5 diopter) was implanted on (b)(6) 2016, into the left eye of a (b)(6) male patient.The surgeon planned to explant the lens on (b)(6) 2016, due to the incorrect diopter size and unexpected visual outcome.Additional information was received and it was learned that the lens was exchanged for another amo lens, same model, with the correct dioptre size for the patient (+21.0 dioptre).No patient injury post-op was reported.No further information was provided.
Additional Manufacturer Narrative
Device available for evaluation: yes.Returned to manufactured on 12/07/2016.Device retuned to manufacturer: yes.Device evaluation: the explanted intraocular lens (iol) was returned to the manufacturing site for investigation.Visual inspection shows the product was cut in pieces and was most probably (likely) to make explant possible.Considering the condition of the returned lens, additional analysis was not possible.The customer's reported event could not be confirmed.Manufacturing record review: the manufacturing records were reviewed.The documentation shows that the production order was manufactured according to specifications.A search of complaints revealed that no similar complaints were received for this production order number.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions, precautions, and warnings for the proper use and handling of the intraocular lenses.Based on the results of the investigation, no product deficiency was identified.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: 6119148
• Report Number: 9614546-2016-00620
• Device Sequence Number: 19009878
• Product Code: HQL
• UDI-Device Identifier: 05050474553293
• UDI-Public: (01)05050474553293(17)200504
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 01/31/2017

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: 05/04/2020
• Device Model Number: ZCT300
• Device Catalogue Number: ZCT300U185
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/26/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/21/2016
• Supplement Report FDA Received Date: 02/01/2017
• 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: 73 YR