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

Model Number	ZXR00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Visual Disturbances (2140); Discomfort (2330); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information: date of event: exact date unknown, information not provided.Best estimate is between august - november 2019.Explant date: not applicable as lens has not been explanted.(b)(4).Device evaluation: product testing could not be performed as the product was not returned as it remains implanted in the patient's eye.The reported event could not be verified.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.A search revealed that no other complaints were received for this production order.Conclusion: based on the investigation, no product deficiency was identified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
Patient called to report that he had a j&j intraocular lens (iol) implanted in his left eye on (b)(6) 2019.He is experiencing a fluttering effect.It's not his eye lid it's his eyeball.His eyeball is moving back and forth, causing a kaleidoscope effect, he sees different colors.Patient sees it more during the day than at night.Patient also has tearing in the eye.Thru follow-up the patient explained that he experienced fluttering shortly after his surgery in november but it could have been sooner.The patient also explained that per his doctor, part of the natural lens might have been left behind(inside the eye).Which might be causing his issues.Initially, the doctor thought his eyelids were fluttering so he prescribed durezol.The patient explained to his doctor that it wasn¿t the eyelid but his actual eye ball.At that point the doctor stopped the durezol prescription.Nothing else was prescribed.The patient underwent a secondary lasik surgery in (b)(6).They were unable to provide the name of the surgery.However, they reported that their vision improved in regards to the kaleidoscope effect and fluttering.However, the symptoms are more frequent throughout the day.The patient could not say exactly how frequent, but explained that his eye does not flutter in the dark.The patient has led lights in his kitchen and that makes his eye flutter.He also feels pressure.Almost as if someone is pressing down on his eye with their thumb.No further 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 nr-0148919 and capa-010215.

• Brand Name: TECNIS SYMFONY
• 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: 10478486
• Report Number: 9614546-2020-00353
• Device Sequence Number: 2949460
• Product Code: POE
• UDI-Device Identifier: 05050474579026
• UDI-Public: (01)05050474579026(17)220514
• 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: 2019
• 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: 05/14/2022
• Device Model Number: ZXR00
• Device Catalogue Number: ZXR00U0165
• 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: 08/05/2020
• Supplement Date Received by Manufacturer: 10/25/2020
• Initial Report FDA Received Date: 09/01/2020
• 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