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

Model Number	ZCT300
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown.An exact date was not provided but the best estimate is (b)(6) 2017.Explant.Incision enlarged.All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that a tecnis toric intraocular lens (model zxt300, +17.0 diopter) was explanted in a secondary surgical procedure on (b)(6) 2017, from the left eye of a female patient.Additional information was received and it was revealed that the incision was enlarged to remove the lens.No vitrectomy was performed, no complications and no other medical or surgical intervention was reported.It was also mentioned that the iol, implanted on (b)(6) 017, was in patient's eye for a month and the doctor felt the power was not right so the lens was explanted and replaced with another toric lens, same model smaller diopter (+14.5).The patient was reported doing well when discharged.No further information was provided.
Additional Manufacturer Narrative
Device evaluation: the intraocular lens (iol) was not returned at 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 intraocular lens were reviewed.The product was manufactured and released according to specification.A search revealed that no similar complaints for this order number have been received.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
• MDR Report Key: 7073609
• Report Number: 9614546-2017-01179
• Device Sequence Number: 16343555
• Product Code: HQL
• UDI-Device Identifier: 05050474553262
• UDI-Public: (01)05050474553262(17)200317
• Combination Product (Y/N): N
• Initial Reporter State: HI
• 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): 12/29/2017

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: 03/17/2020
• Device Model Number: ZCT300
• Device Catalogue Number: ZCT300U170
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/01/2017
• Supplement Date Received by Manufacturer: 12/01/2017
• Initial Report FDA Received Date: 11/30/2017
• Supplement Report FDA Received Date: 12/29/2017
• 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