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

Model Number	ZMB00
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Unintended Movement (3026)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/08/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Explant date: if explanted, give date: not applicable, as the lens remains implanted.  (b)(4).It was indicated that the device is not returning for evaluation as it remains implanted; therefore a failure analysis of the complaint device cannot be completed.A review of the device/lot history record, labeling, 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.All pertinent information available to johnson and johnson surgical vision has been submitted.
Event or Problem Description
It was reported that the lens was implanted in patient¿s right eye that had capsular tear.Lens dislocated post operatively and was noticed on day 54 post implantation.The lens was planned to be explanted in secondary surgery because of patient experiencing cloudy vision, double vision and decreased visual acuity.Reportedly the lens was scheduled to be explanted on (b)(6) 2018.Additional information was received, and it was learnt that surgery was aborted due to unstable capsule.One 10-0 suture was used on the primary incision which was not enlarged.Patient was doing fine.The lens is still implanted.Visual acuity pre-op - 20/400 bcva (best corrective visual acuity).Visual acuity post-op - 20/100, pinhole 20/60.No further information provided.
Additional Manufacturer Narrative
The product testing could not be performed as the product was not returned.The reported complaint cannot be confirmed.The manufacturing process record was evaluated and no deviation was found during process related to the complaint issue reported.There was no discrepancy found during the review.The product was manufactured and released according to specifications.A search revealed that no other complaints were received for this production order.The directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the product.Based on the investigation results there is no indication of a product quality deficiency.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.; santa ana CA
• MDR Report Key: 8109533
• Report Number: 3011852734-2018-00221
• Device Sequence Number: 16709588
• Product Code: MFK
• UDI-Device Identifier: 05050474535626
• UDI-Public: (01)05050474535626(17)220306
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/05/2020
• 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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/06/2022
• Device Model Number: ZMB00
• Device Catalogue Number: ZMB00U0200
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 10/31/2018
• Supplement Date Received by Manufacturer: 12/17/2018; 10/25/2020
• Initial Report FDA Received Date: 11/28/2018
• Supplement Report FDA Received Date: 12/28/2018; 11/05/2020
• 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: 71 YR
• Date Report Sent to FDA: 01/01/2005