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	Dry Eye(s) (1814); Blurred Vision (2137)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown, an exact date not provided; however, reported as right after lenses were implanted.The device has not been returned 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 & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
The patient called to report he has blurry vision, he can't read anything, when watching tv he can tell it's a person; however, he can not see the details of their face.It has been like this for over a year.He states he had several appointments with his doctor and the doctor only offered a free pair of glasses and a couple hundred dollars.In follow up conversation with the patient, he reported that right after implant of his intraocular lenses, he was not seeing well.He returned to his doctor who performed, what he thinks were yag laser procedures, on both his eyes.He wasn't exactly sure of the procedure name.The patient started getting floaters really bad after that.He was not treated specifically with any type of medication for the floaters.The patient stated he thinks he had laser twice.Once in the office in (b)(6) and then another time in the doctor¿s office, (b)(6).Second time wasn't laser, because the laser equipment was not available.The patient stated the doctor scraped his eye, he thinks, because his eye had a little blood afterwards.He has also developed dry eyes since surgery, (did not have before surgery).Patient takes eye vitamins, and uses over the counter drops, maybe systhane, nothing prescription.Doctor had no more recommendations for him so he went to see another doctor.The second doctor stated that the lenses are implanted perfectly, no issues.The patient was told sometimes the doctor doesn't get the exact intraocular lens prescription just right.He was told he could have another laser procedure in each eye.Patient stated he used to have good vision distance, needed glasses to read before the lens implants only.Post surgery he can see, drive and do daily activities with the glasses.The eye vitamins are called eye relief and they have helped him.He is happy with his vision; but as a house painter he wanted to be free from glasses.No further information was provided.Patient had bilateral lens implants.This report represents one of the two lenses implanted.
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: 8220449
• Report Number: 9614546-2019-00012
• Device Sequence Number: 10814831
• Product Code: MFK
• UDI-Device Identifier: 05050474560703
• UDI-Public: (01)05050474560703(17)181127
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2020
• 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: 11/27/2018
• 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: 12/07/2018
• Supplement Date Received by Manufacturer: 10/25/2020
• Initial Report FDA Received Date: 01/04/2019
• Supplement Report FDA Received Date: 11/06/2020
• 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
• Patient Age: 63 YR
• Date Report Sent to FDA: 01/01/2005