MAUDE Adverse Event Report: JOHNSON AND JOHNSON SURGICAL VISION, INC. 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	Blurred Vision (2137); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Explant date: if explanted, give date: not applicable at this time; however, a planned explant is schedule for (b)(6) 2018.(b)(4).All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that an intraocular lens (iol) was implanted in the patient's right eye on (b)(6) 2018.It will be later explanted in a secondary surgical procedure planned for (b)(6) 2018, and replaced with another manufacturer's lens.The reason for the upcoming explant was not provided.Reportedly, there was no additional medical or surgical interventions performed or planned during the initial surgery.The patient was reported doing fine when discharged.Further, the patient's daily activities are affected.No further information was provided.
Additional Manufacturer Narrative
Device evaluation: the device was not returned at 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 device were reviewed.The product was manufactured and released according to specification.Historical data analysis: a complaint history search revealed that no similar complaints were received for this production order number to date.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.The complaint cannot be confirmed all pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information was received and it was learnt that the intraocular lens (iol) was planned to be explanted because the male patient was experiencing blurry vision which was affecting his daily activities.Further, it was initially reported that the lens explant was scheduled for may 11, 2018; however, to date, the lens has not been explanted.Lens explant is still planned; but a specific date has not been provided.Therefore updating the following fields: sex/gender: male.(b)(4).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): JOHNSON AND JOHNSON SURGICAL VISION, INC.; santa ana CA
• MDR Report Key: 7465459
• Report Number: 9614546-2018-00402
• Device Sequence Number: 11133508
• Product Code: MFK
• UDI-Device Identifier: 05050474560475
• UDI-Public: (01)05050474560475(17)190601
• Combination Product (Y/N): Y
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/23/2018
• 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: 06/01/2019
• Device Model Number: ZLB00
• Device Catalogue Number: ZLB00U0100
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 03/28/2018
• Supplement Date Received by Manufacturer: 04/30/2018; 07/09/2018
• Initial Report FDA Received Date: 04/26/2018
• Supplement Report FDA Received Date: 05/30/2018; 07/23/2018
• 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: 77 YR
• Date Report Sent to FDA: 01/01/2005