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

Model Number	ZMB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Blurred Vision (2137); Visual Impairment (2138)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown, not provided, but the best estimate is (b)(6) 2019.If explanted; give date: not applicable, lens remains implanted.(b)(4).Device evaluation: the product testing could not be performed as the product was not returned (the lens remains implanted).The reported complaint cannot be confirmed.Manufacturing records review: the manufacturing records for the device were reviewed and no deviation or nonconformance reports related to this production order were found.The product was manufactured and released according to specifications.A search in complaint history revealed that one (1) additional complaint was received from this production order number; however, the complaint is not related to this event, and since it was of low risk; therefore, no investigation was required.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 & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
A female patient reported that she had 20/20 vision right after surgery on her left eye (os).However, lately she noticed that her vision is getting worse and worse, she needs to put things right next to her face to read the item.The patient has eye pain sporadically and gets a sharp pain in her eye off and on which started last year.Her doctor recommended to the patient to see an eye specialist for a routine eye exam.On (b)(6) 2020, the patient indicated that she is still not able to see near or far well and her vision is blurry, not clear.The patient noted that the lens was to correct her far and near vision.Reportedly, the patient¿s problem with the left eye started about 5-6 months ago, she noticed her vision is not as good, not clear as it used to be.The patient was given readers but she still has issues with this eye.The patient cannot recognize people even with the readers, unless they are within 12 feet distance from her.Recently, the patient was referred to a specialist who indicated that there was no issue with the lens.The specialist asked the patient to return in two weeks and they could suction out the cloudy part/the film underneath the lens.No clarification was provided by the doctor to the patient as to what the issue was.The patient reported she has not been able to go back for treatment of the cloudy film in her eye as the doctor postponed the appointment due to the covid-19 pandemic issue.The patient is not able to drive at all at night time as she cannot see well.The patient also noted that her physician assistant (pa) and doctors informed her that she also has fold/wrinkle in her left eye which according to the doctor is either due to an injury prior to cataract or it occurred at the time of cataract surgery.The patient was told that the fold/wrinkle issue will resolve on its own.The patient will go back for treatment after the covid-19 pandemic and as soon as her doctor is ready to treat her.No additional information was 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 (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: 9999017
• Report Number: 2648035-2020-00389
• Device Sequence Number: 14427127
• Product Code: MFK
• UDI-Device Identifier: 05050474535701
• UDI-Public: (01)05050474535701(17)171204
• 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: 2015
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2020
• 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: 12/04/2017
• Device Model Number: ZMB00
• Device Catalogue Number: ZMB00U0240
• 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: 03/30/2020
• Supplement Date Received by Manufacturer: 10/25/2020
• Initial Report FDA Received Date: 04/25/2020
• Supplement Report FDA Received Date: 11/02/2020
• 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: Other
• Date Report Sent to FDA: 01/01/2005