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

Model Number	ZLB00
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Corneal Scar (1793); Pain (1994); Blurred Vision (2137); Visual Impairment (2138); Visual Disturbances (2140); Capsular Bag Tear (2639); Vitrectomy (2643); No Code Available (3191)
Date of Event	04/12/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).All pertinent information available to the manufacturer has been submitted.
Event or Problem Description
It was reported that a zlb00 23.0 diopter intraocular lens was explanted due to patient experiencing starburst.The physician feels there may be a defect in this lens which is causing unusual glare.Further clarification was provided by the physician that the defect was in a starburst that she was having in that eye that was not correctable with refraction or any other treatment.No other pathology in this eye.Defect was not visible.There was a capsule tear and vitrectomy performed and the incision was enlarged when removing the lens.The patient is doing well but the refraction has not yet settled.No further information was provided.
Additional Manufacturer Narrative
Additional information received reported that immediately after implantation of the defective lens, the patient began to experience a number of problems with her left eye, including, but not limited to, severe pain, blurred vision, and various issues with her vision in general.The patient was also unable to see at night and would have to cover her left eye in order to see.During the day, the patient would see bright starbursts around any light source, which effectively deprived her of vision in her left eye.Reportedly, even thought the patient had the lens explanted, damage and vision problems in the left eye still are present.The patient has received other treatments post-operatively and damage to her left eye and vision has not significantly improved.No additional information was provided.(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Device evaluation: the intraocular lens (iol) was not returned to the manufacturing site.Therefore, product testing could not be performed and 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 on complaints revealed that no similar 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 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
(b)(4).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
• MDR Report Key: 6557530
• Report Number: 9614546-2017-00393
• Device Sequence Number: 10937825
• Product Code: MFK
• UDI-Device Identifier: 05050474560734
• UDI-Public: (01)05050474560734(17)181126
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/04/2018

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: 11/26/2018
• Device Model Number: ZLB00
• Device Catalogue Number: ZLB00U0230
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/12/2017
• Supplement Date Received by Manufacturer: 08/08/2017; 02/06/2018; 05/07/2018
• Initial Report FDA Received Date: 05/10/2017
• Supplement Report FDA Received Date: 09/01/2017; 03/07/2018; 06/05/2018
• 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: 57 YR