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	03/08/2017
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 an intraocular lens (iol) was explanted in a secondary surgical procedure because the patient was complaining of halos and glare.The lens was replaced with a non-amo lens, model and diopter unknown.Additional information was received and it was learnt that there was no patient injury, no capsule tear and no vitrectomy was performed.The incision had to be enlarged and 3 or 4 sutures were required.The patient was reported doing well.No further information was provided.
Additional Manufacturer Narrative
Device available for evaluation? yes.Returned to manufacturer on: 07/18/2017.Device returned to manufacturer? yes.Device evaluation: the intraocular lens (iol) was returned at the manufacturing site for evaluation.Visual inspection at 10x microscope magnification showed loose fibers/particles on the lens related to the handling of the unit out of a sterile environment.The lens was observed torn.The customer's reported complaint could not be verified.Manufacturing records review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.A search revealed that no additional investigation requests for this order number have been received.Labeling review: the directions for use (dfu) were reviewed.The directions for use (dfu) adequately provides instructions and precautions along with warnings for the proper use and handling of the device.As a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.All pertinent information available to abbott medical optics has been submitted.
Additional Manufacturer Narrative
Additional information was received and it was learnt that the multifocal intraocular lens (zmb00 +18.5 diopter) was implanted in the left eye (os) of the patient on (b)(6) 2016.During the follow up visit on (b)(6) 2017 the patient stated that his vision was not much better and complained of starbursts in os - he commented that he has to close the left eye to see clearly when driving.On (b)(6) 2017 the lens was explanted and replaced with a three-piece non j&j iol (+18.0 diopter) as the patient was complaining of blurry vision, decreased night vision and persistent halos and glare when driving at night.One day post explantation ((b)(6) 2017) the patient stated that his visual acuity was still very blurry and the night before was a little uncomfortable and very scratchy.No further information was provided.Updated the following fields: if implanted, give date: (b)(6) 2016.All pertinent information available to johnson and 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
• MDR Report Key: 6549781
• Report Number: 2648035-2017-00817
• Device Sequence Number: 83644
• Product Code: MFK
• UDI-Device Identifier: 05050474535596
• UDI-Public: (01)05050474535596(17)190120
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/29/2018

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: 01/20/2019
• Device Model Number: ZMB00
• Device Catalogue Number: ZMB00U0185
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2017
• Initial Date Received by Manufacturer: 04/07/2017
• Supplement Date Received by Manufacturer: 07/19/2017; 03/01/2018
• Initial Report FDA Received Date: 05/05/2017
• Supplement Report FDA Received Date: 08/11/2017; 03/29/2018
• 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
• Patient Age: 75 YR