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

Model Number	ZCT450
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 explant is not applicable at this time.Explant is planned.(b)(4).All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
A report was received that a tecnis monofocal model zct450 16.5 diopter intraocular lens (iol) was planned for explant from a patient¿s left operative eye as there was nearly 2.00 diopters of residual astigmatism.The surgery center indicated the patient required a zct600 17.0 diopter iol to correct the problem.No further information was provided.
Additional Manufacturer Narrative
Additional information received reported the patient was (b)(6) and the explant date was (b)(6) 2017.Furthermore, there was a slight incision enlargement with no vitrectomy or sutures used.There was no post-operative patient injury or problems and the patient is happy with the new lens.The lens was replaced with a different diopter of 17.0 with 6.00 cylinder.No additional information was provided.Age/date of birth: (b)(6).If explanted, give date: (b)(6) 2017.(b)(4).All pertinent information available to abbott medical optics has been submitted.
Additional Manufacturer Narrative
Correction: the supplement mdr #1 should have included ''required intervention'' in outcomes to adverse event.The following sections have been updated accordingly.Outcomes attributed to adverse event: required intervention.All pertinent information available to abbott medical optics has been submitted.Placeholder.
Additional Manufacturer Narrative
Device available for evaluation ¿ yes, returned to manufacturer on 10/23/2017.Device returned to manufacturer ¿ yes.Device evaluation: the device was returned to the manufacturer.Visual inspection with 12x magnification shows the product is contaminated, dust particles are present.This is expected as the lens was transported from controlled environment during manufacturing to a non-sterile, non-environmental controlled area.There were no other anomalies found.The customer's reported event could not be confirmed.Manufacturing records were reviewed and the lens was manufactured according to specification.A search on complaints revealed that no other complaints have been 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 device.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: 6772537
• Report Number: 9614546-2017-00710
• Device Sequence Number: 725384
• Product Code: HQL
• UDI-Device Identifier: 05050474602915
• UDI-Public: (01)05050474602915(17)201002
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,Followup,Followup
• Report Date (Section B): 12/19/2017

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: 10/02/2020
• Device Model Number: ZCT450
• Device Catalogue Number: ZCT450U165
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2017
• Initial Date Received by Manufacturer: 07/13/2017
• Supplement Date Received by Manufacturer: 09/07/2017; 11/15/2017; 12/19/2017
• Initial Report FDA Received Date: 08/07/2017
• Supplement Report FDA Received Date: 10/03/2017; 12/13/2017; 12/19/2017
• 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: Other; Required Intervention
• Patient Age: 61 YR