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	Therapeutic Effects, Unexpected (2099); Blurred Vision (2137)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown, exact date not provided, best estimate is between (b)(6) 2020-(b)(6) 2020.If explanted, give date: not applicable, remains implanted in the eye.Device evaluation: the product testing could not be performed as the product was not returned as the lens remains implanted.The reported complaint cannot be confirmed.Manufacturing records review: the manufacturing records for the device were reviewed.The product was manufactured and released according to specification.A search in complaint system revealed no other complaints has been received for this production order number.Conclusion: 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 and johnson surgical vision has been submitted.
Event or Problem Description
It was reported that the patient had undergone bilateral lens implants.The left eye was implanted on (b)(6) 2020 with a model zlb00 lens and is the one giving her issues.She feels she can¿t read the way she anticipated.She had model zxr00 implanted her right eye on (b)(6) 2020 and can see fine with it.She could read fine directly after surgery, however it started to deteriorate after, to where she doesn¿t have the sharpness she originally experienced.She said her eye feels heavy, but there is no pain.She said it feels cloudy, or slightly blurred.She has seen her surgeon twice, and the surgeon said it looks ok and wants to look at it again at 3-months and will evaluate whether she will need a laser adjustment to address any scar tissue that may have developed.The implanting surgeon moved, but she went to other surgeon in same facility who said to put a warm cloth on it.She was told she has dry eye and was recently prescribed restasis.She said when she uses refresh eye drops, makes it feel a little better but it doesn¿t improve sharpness.She has mild hypertension, but doesn¿t feel it should impact this.Additional information was received and it was learnt that patient¿s normal daily activities are fine and she does not drive much at night.However, the biggest issue she has is reading.She does have cloudiness and has been using prescribed eye drops.No further information provided.
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: 10280473
• Report Number: 9614546-2020-00251
• Device Sequence Number: 19441070
• Product Code: MFK
• UDI-Device Identifier: 05050474560741
• UDI-Public: (01)05050474560741(17)230502
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2020
• 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: 05/02/2023
• Device Model Number: ZLB00
• Device Catalogue Number: ZLB00U0235
• 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: 06/18/2020
• Supplement Date Received by Manufacturer: 10/25/2020
• Initial Report FDA Received Date: 07/15/2020
• Supplement Report FDA Received Date: 10/29/2020
• 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