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

Model Number	ZCT225
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown, not provided, but the best estimate date is between (b)(6) 2017.(b)(4).All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that a zct225 15.0 diopter intraocular lens (iol) was implanted into the patient's operative eye on (b)(6) 2017.It was later explanted on (b)(6) 2017, due to poor post-operative visual outcome.The replacement lens was a zct300 14.0 diopter iol.No additional information was provided.
Additional Manufacturer Narrative
Device available for evaluation? yes.Returned to manufacturer on: 11/10/2017.Device returned to manufacturer? yes.Device evaluation: the intraocular lens (iol) was returned at the manufacturing site for evaluation.Visual inspection showed that the lens was cut in pieces, most probably to make the explant possible.Considering the condition of the lens additional analysis was not possible.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.Labeling review: the directions for use (dfu) were reviewed.The directions for use (dfu) adequately provides instructions and precautions along with warnings for the proper use and handling of the device.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.
Additional Manufacturer Narrative
Additional information was provided and it was learnt that the zct225 15.0 diopter intraocular lens (iol) was explanted from the right eye of a (b)(6) year-old female patient.Reportedly, there were no complications when removing the lens.The patient was reported doing fine post-op.No further information was provided.Updated the following fields: age/date of birth: (b)(6).Gender/sex: female.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS
• Common Device Name: TORIC IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA 92705
• MDR Report Key: 7026955
• Report Number: 9614546-2017-01107
• Device Sequence Number: 940064
• Product Code: HQL
• UDI-Device Identifier: 05050474552630
• UDI-Public: (01)05050474552630(17)190316
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/21/2018

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: 03/16/2019
• Device Model Number: ZCT225
• Device Catalogue Number: ZCT225U150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2017
• Initial Date Received by Manufacturer: 10/17/2017
• Supplement Date Received by Manufacturer: 12/07/2017; 03/22/2018
• Initial Report FDA Received Date: 11/13/2017
• Supplement Report FDA Received Date: 01/05/2018; 04/22/2018
• 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: 78 YR