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 Codes	Visual Disturbances (2140); Halo (2227); 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 during 2017.Explant date: if explanted, give date: not applicable, as the lens remains implanted.However, there is a planned explant in the near future.(b)(4).All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that a zlb00 22.5 diopter intraocular lens (iol) is planned to be explanted from the patient's operative eye because the patient experienced haze and requested an explant.No additional information was provided.
Additional Manufacturer Narrative
Additional information was received indicated that the intraocular lens model zlboo, 22.5 diopter was implanted in the left eye (os) of the female patient on (b)(6) 2017.The lens was later explanted on (b)(6) 2017 because the patient was complaining of seeing halos all the time.There was no incision enlargement to remove the lens, no vitrectomy was performed, no sutures were used and no patient injury was reported.A non-j&j lens (22.5 diopter) was implanted as a replacement.Post-op the patient was reported as 20/25 -2.The following fields were updated based on the new information received: age/date of birth: (b)(6).Gender/sex: female.Outcomes attributed to adverse event: updated from other to required intervention if implanted, give date: (b)(6) 2017.If explanted, give date: (b)(6) 2017.(b)(6).Health professional: yes.Occupation: physician.(b)(6).Device evaluation: visual inspection/product testing could not be performed as the product was not returned for evaluation.The reported complaint could not be verified.Manufacturing record review: manufacturing records were reviewed and the lens was manufactured according to specification.A search on complaints revealed no similar complaints were received for this production order number to date.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the intraocular lenses.Conclusion: based on the investigation results there is no indication of a product quality deficiency.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Device available for evaluation? yes.Returned to manufacturer on: 5/29/2018.Device returned to manufacturer? yes.Device evaluation: the product was received sealed in a pouch.Visual inspection with the unaided eye showed that the product 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.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: 7057341
• Report Number: 9614546-2017-01160
• Device Sequence Number: 102381
• Product Code: MFK
• UDI-Device Identifier: 05050474560727
• UDI-Public: (01)05050474560727(17)190812
• Combination Product (Y/N): Y
• Initial Reporter State: MO
• 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): 07/18/2018
• Report Date (Section F): 01/01/2005

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: 08/12/2019
• Device Model Number: ZLB00
• Device Catalogue Number: ZLB00U0225
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 10/27/2017
• Supplement Date Received by Manufacturer: 03/08/2018; 06/25/2018
• Initial Report FDA Received Date: 11/23/2017
• Supplement Report FDA Received Date: 04/06/2018; 07/18/2018
• 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: Other; Required Intervention
• Patient Age: 62 YR
• Date Report Sent to FDA: 01/01/2005