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

Model Number	ZMB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Halo (2227); No Code Available (3191)
Date of Event	11/02/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that a patient who had a zmb00 multifocal intraocular lens (iol) implanted in the right eye, has had it removed by a different surgeon than the reporting surgeon.The patient visited the surgeon who performed the explant on a number of occasions following the implant and at each visit the complaint was blurred vision, halos, glare, light sensitivity and inability to drive.The patient's visual acuity pre-op (initial implant) was 20/30.Her visual acuity post-op (initial implant) was 20/80.The explanted lens (zmb00) was replaced with a model pcb00 (23.5 diopter) iol.The patient is doing well after the replacement procedure; visual acuity is 20/20 uncorrected.There was no incision enlargement or vitrectomy required during the replacement procedure.There was no lens rotation noticed prior to the explant.No treatments or prescriptions were given by the surgeon who performed the replacement.No additional information was provided to abbott medical optics.
Additional Manufacturer Narrative
The product was not returned for investigation.Manufacturing records review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specifications.A search revealed that no additional complaints for this order number have been received.Labeling review: the directions for use (dfu) were reviewed.The dfu adequately provide instructions and precautions along with warnings for the proper use and handling of the device.Conclusion: the reported issue was not verified.As a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to abbott medical optics has been submitted.

• Brand Name: TECNIS 1 MULTIFOCAL
• Common Device Name: MULTIFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 5926268
• Report Number: 2648035-2016-01384
• Device Sequence Number: 599726
• Product Code: MFK
• UDI-Device Identifier: 05050474535701
• UDI-Public: (01)05050474535701(17)170319
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2016

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: 03/19/2017
• Device Model Number: ZMB00
• Device Catalogue Number: ZMB00U0240
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/09/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/02/2016
• Supplement Report FDA Received Date: 09/27/2016
• 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: 60 YR