MAUDE Adverse Event Report: JOHNSON & 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	Visual Impairment (2138); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: exact date not provided however best estimate is between 2/20/2019 - 4/17/2019.If explanted, give date: not applicable, an explant is planned, however not confirmed.(b)(4).Attempts have been made to obtain missing information; however, no 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 the patient became too hyperopic post-operative.The patient was disappointed she could not read.In the first week, the patient's vision was 20/25, j12.At the third week vision acuity was 20/50.Refraction spherical equivalent (se) +0.75d.It was stated, most likely the elp (estimated lens position) shifted posteriorly as the capsule contracted.The doctor planned on explanting the lens from the left eye and replacing it with another zlb00 of a higher diopter 22.5.No additional information was provided to johnson & johnson surgical vision.
Additional Manufacturer Narrative
Additional info: through follow-up the it was reported that the planned explant did not occur, the surgeon decided to implant a non j&j piggyback lens and a limbal relaxing incision (lri) was performed.The surgeon was able to correct the patient's hyperopic surprise.No other information was provided.As a result of the additional information the patient code 3191 for planned explant provided in the initial mdr is no longer applicable.The following patient codes have been added: 3191 - placement of piggyback lens in a secondary procedure.3191 - limbal relaxing incision (lri) procedure.Device evaluation: the device was not returned at the manufacturing site as the lens remains implanted; therefore; product testing could not be performed, and the customer¿s reported complaint could not be verified.Manufacturing record review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured according to specifications.The search revealed that no similar complaint for this production order number has been received.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 product.Conclusion: as a result of the investigation 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 (b)(4) 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: 8614497
• Report Number: 9614546-2019-00462
• Device Sequence Number: 11265364
• Product Code: MFK
• UDI-Device Identifier: 05050474560703
• UDI-Public: (01)05050474560703(17)200524
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/11/2020
• 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: 05/24/2020
• Device Model Number: ZLB00
• Device Catalogue Number: ZLB00U0215
• 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: 04/17/2019
• Supplement Date Received by Manufacturer: 05/14/2019; 10/25/2020
• Initial Report FDA Received Date: 05/16/2019
• Supplement Report FDA Received Date: 06/12/2019; 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
• Date Report Sent to FDA: 01/01/2005