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	Halo (2227); No Code Available (3191)
Date of Event	10/27/2016
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 after implantation of a zmb00 20.0 diopter intraocular lens(iol), the patient experienced a refractive surprise, halos/glare issues that has affected the patient's daily activities.Lens was explanted (b)(6) 2016 and replaced with a zcb00 20.0 diopter iol.There were no incision enlargement, vitrectomy or lens rotation performed.Patient is now happy with his vision after the lens replacement.Patient's visual acuity: visual acuity pre-op (pre-initial implant): 20/30-1.Visual acuity post-op (post-initial implant): 20/25-2.Visual acuity post-op (post-replacement): 20/20.No further information was provided.
Additional Manufacturer Narrative
Corrected data: it was known at the time of the initial mdr that treatment or prescription given by the doctor was eye drops, besivance, lotemax gel, prolensa.However this information was inadvertently not included in the initial report.Device evaluation: the device was not returned to the manufacturer for evaluation.Visual evaluation could not be performed, therefore the reported complaint could not be verified.Manufacturing records were reviewed and the lens was manufactured according to specification.The complaint history search revealed no other complaints for this production order number has been received.The directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the intraocular lenses.Based on the investigation results 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: 6197316
• Report Number: 9614546-2016-00704
• Device Sequence Number: 1070562
• Product Code: MFK
• UDI-Device Identifier: 05050474535626
• UDI-Public: (01)05050474535626(17)180127
• 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: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2017

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: 01/27/2018
• Device Model Number: ZMB00
• Device Catalogue Number: ZMB00U0200
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/28/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/21/2016
• Supplement Report FDA Received Date: 02/01/2017
• 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: Required Intervention
• Patient Age: 60 YR