MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. TECNIS IOL; LENS, MULTIFOCAL INTRAOCULAR

Model Number	ZLB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	05/03/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient age, weight and ethnicity: unknown/ not provided.If explanted, give date: unknown, not provided.Best estimate of date of event is on (b)(6) 2022.The device is not returned; therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record, complaint trending, and risk documentation for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.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 due to dissatisfied patient and residual refractive error that is unacceptable.It was stated that doctor used lenstar biometer and the quantal ascan.No other information was provided.
Additional Manufacturer Narrative
Additional information: new information came in with the product return.Patient date of birth: (b)(6) 1952, 69 yrs.Old, male, explant date: (b)(6) 2022.Fields below updated: section a2: age: 69 yrs.Old.Section a2: date of birth: (b)(6) 1952.Section a3: gender: male.Section d6b: if explanted, give date: (b)(6) 2022.Section d9.Device available for evaluation? yes.Returned to manufacturer on: aug.18, 2022.Section h3.Device evaluated manufacturer? yes.Device evaluation: visual inspection under magnification revealed that the complaint lens was received cut in half.The lens was cleaned and, no issues that could contribute to a poor visual outcome could be identified.Based on the return condition of the lens, no further product evaluation can be performed.The complaint issues were not confirmed.The other observed issues during the product evaluation could not be confirmed to be related to a manufacturing or design issue.Therefore, there is no indication of a product deficiency or product malfunction.Conclusion: as a result of the investigation there is no indication of a product quality deficiency or product malfunction.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Corrected data: upon further review it was noted that it was inadvertently missed to explain in h10 text in the initial report submitted that "section d3: manufacturer: device was manufactured at the (b)(4) in malaysia; however, this site has been closed".Therefore, this correction report is being submitted to explain this.Section d3: manufacturer: device was manufactured at (b)(4) in malaysia; however, this site has been closed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS IOL
• Common Device Name: LENS, MULTIFOCAL INTRAOCULAR
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 31 technology drive; irvine CA 92618
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 15071457
• Report Number: 3012236936-2022-01898
• Device Sequence Number: 5516027
• Product Code: MFK
• UDI-Device Identifier: 05050474560659
• UDI-Public: (01)05050474560659(17)220711
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/30/2022

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: Health Professional
• Device Expiration Date: 07/11/2022
• Device Model Number: ZLB00
• Device Catalogue Number: ZLB00U0190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2022
• Supplement Date Received by Manufacturer: 08/29/2022; 08/29/2022
• Initial Report FDA Received Date: 07/21/2022
• Supplement Report FDA Received Date: 08/30/2022; 08/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/11/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male