MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. TECNIS 1 MULTIFOCAL; MULTIFOCAL IOLS

Model Number	ZLB00
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Codes	Halo (2227); No Code Available (3191)
Date of Event	07/09/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event, exact date unknown/not provided.Best estimate date is between (b)(6) 2019-(b)(6) 2019.(b)(4).Device evaluation: the product associated to the complaint was received on 10/29/2019 in a plastic bag.The lens was received with traces of what appears to be viscoelastics.Particles are observed on the lens; these could be related to the handling of the lens in a surgical stage.Limited information was received.Customer has not responded to attempt to obtain more information regarding the mechanical failure (as described by the customer) reported; the reported issue could not be verified.Based on the product return evaluation there is no indication of a product quality deficiency.Manufacturing records review: the manufacturing process record was evaluated and revealed that the product was manufactured and released according to specifications.A search revealed that no other complaint has been received for this production order number.Conclusion: as a result of the investigation there is no indication of a quality product deficiency.Attempts have been made to obtain missing information; however, no definitive response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that an intraocular lens (iol) was explanted from the patient's left eye due to a mechanical failure.The incision was enlarged, however, no additional intervention was required.No additional information was provided to johnson & johnson surgical vision.
Additional Manufacturer Narrative
Additional info: further information was provided reporting the date the issue was first noticed, and that the patient had severe halos with night driving.The visual symptom could not be resolved with prescription spectacles.The lens was replaced with another model and lower diopter lens.The patient was stable when discharged.The following section has been updated accordingly: date of event: (b)(6) 2019.(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
This correction mdr is being submitted to address inaccurate information in section f on the xml version of the previous submission caused by a software glitch in the transmission process.The internal non-conformance numbers for this software issue are nr-0148919 and capa-010215.

• Brand Name: TECNIS 1 MULTIFOCAL
• Common Device Name: MULTIFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 9283420
• Report Number: 2648035-2019-01172
• Device Sequence Number: 2448588
• Product Code: MFK
• UDI-Device Identifier: 05050474560765
• UDI-Public: (01)05050474560765(17)221017
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/06/2020
• 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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/17/2022
• Device Model Number: ZLB00
• Device Catalogue Number: ZLB00U0245
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2019
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 10/09/2019
• Supplement Date Received by Manufacturer: 11/08/2019; 10/25/2020
• Initial Report FDA Received Date: 11/06/2019
• Supplement Report FDA Received Date: 12/05/2019; 11/06/2020
• 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: 69 YR
• Date Report Sent to FDA: 01/01/2005