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

Model Number	ZLB00
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Blurred Vision (2137); No Code Available (3191)
Date of Event	05/06/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown, not provided.(b)(4).Device evaluation: the intraocular lens (iol) was returned to the manufacturing site for evaluation.Visual inspection found residue of lubricant material on the lens.The lens was observed to be in good condition.The condition of the lens returned is consistent with a unit that has been previously used in a surgical process.The complaint issue reported could not be verified.Manufacturing records review: the manufacturing records for the product was reviewed.The product was manufactured and released according to specification.A search on complaints revealed that no other 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 johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a zlb00 intraocular lens (iol) was removed and exchanged from the left eye.The iol had decentered, and was exchanged for a sulcus zma00 iol.There was no intervention required and the patient was doing fine post-operatively.No additional information was provided.
Additional Manufacturer Narrative
Additional information received revealed the patient reported on (b)(6) 2019 having blurry vision.The doctor that the intraocular lens (iol) had decentered slightly.There were no injuries during the explant and the patient is doing fine.As a result the following fields have been updated: 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: 8681031
• Report Number: 3011852734-2019-00121
• Device Sequence Number: 1875446
• Product Code: MFK
• UDI-Device Identifier: 05050474560635
• UDI-Public: (01)05050474560635(17)210814
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/12/2020
• 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: 08/14/2021
• Device Model Number: ZLB00
• Device Catalogue Number: ZLB00U0180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2019
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 05/10/2019
• Supplement Date Received by Manufacturer: 06/18/2019; 10/25/2020
• Initial Report FDA Received Date: 06/07/2019
• Supplement Report FDA Received Date: 07/17/2019; 11/12/2020
• 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: 78 YR
• Date Report Sent to FDA: 01/01/2005