MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS TECNIS 1 MULTIFOCAL; MULTIFOCAL IOLS

Model Number	ZLB00
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.If explanted, give date: not applicable, however an explant is scheduled for (b)(6) 2018.(b)(4).Attempts have been made to obtain missing information; however, to date, no response has been received.All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that a zlb00 18.5 diopter intraocular lens (iol) was implanted in the patient's operative eye.However, an explant is planned to be performed due to the patient not adapting well to the iol.No additional information was provided.
Additional Manufacturer Narrative
Device available for evaluation? yes, returned to manufacturer on: 3/20/2018, device returned to manufacturer? yes.Device evaluation: the intraocular lens (iol) was returned to the manufacturer.Visual inspection of the returned sample shows the lens was cut in pieces, most probably to make explant possible.Considering the condition of the lens additional analysis is not possible.The complaint event is not confirmed.Manufacturing record review: the manufacturing process record was evaluated.The product was manufactured and released according to specifications.A search on complaints related to this production order was conducted.The search revealed no other complaints have been received for this production order number.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the product.Conclusion: based on the investigation results there is no indication of a product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information received confirmed that the lens explant was performed on (b)(6) 2018.It was further reported that the patient did not have any contributing medical history and there were no complications post lens exchange.There was no patient outcome concerns with regards to the procedure and there was no serious patient injury reported.There was no incision enlargement, no vitrectomy, or sutures used.A replacement lens from another manufacturer was used.If explanted, give date: (b)(6) 2018.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS 1 MULTIFOCAL
• Common Device Name: MULTIFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA 92705
• MDR Report Key: 7262694
• Report Number: 3011852734-2018-00016
• Device Sequence Number: 1035892
• Product Code: MFK
• UDI-Device Identifier: 05050474560642
• UDI-Public: (01)05050474560642(17)210528
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/27/2018

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: 05/28/2021
• Device Model Number: ZLB00
• Device Catalogue Number: ZLB00U0185
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2018
• Initial Date Received by Manufacturer: 01/15/2018
• Supplement Date Received by Manufacturer: 03/06/2018; 04/02/2018
• Initial Report FDA Received Date: 02/12/2018
• Supplement Report FDA Received Date: 04/03/2018; 04/27/2018
• 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