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	Vitreous Floaters (1866); Swelling (2091); Blurred Vision (2137)
Date of Event	12/16/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If explanted; give date: n/a (not applicable).The lens remains implanted.(b)(4).Device evaluation: the device was not returned at the manufacturing site; 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.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be confirmed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the patient is experiencing blurred vision in the left eye with an intraocular lens (iol).Patient reported distance vision is much worse than before the surgery.Patient can read business cards and letters just fine as that got better, however, patient feels left eye does not feel right.Patient also reported having swelling in the eye, was sent to a retinal specialist, then was given steroid eye drops to treat the swelling.The swelling went down and got better, but patient says eye does not feel the same.Patient complains peripheral is off, and when driving vision is not as good-it is blurry/hazy/not as crisp of vision.Visual issues interfere with daily activities.Patient wears prescription sunglasses, so eye can adjust and wears glasses for distance.The surgeon informed patient the lens is perfectly placed and there is no adhesion.No other treatment has been provided.At this time, the lens remains implanted.No additional information was provided.
Additional Manufacturer Narrative
Corrected data: upon further review, it was noted that in the initial mdr section g4 had the incorrect date received by manufacturer.The correct date is 8/21/2020.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• 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: 10548976
• Report Number: 2648035-2020-00693
• Device Sequence Number: 3344675
• Product Code: POE
• UDI-Device Identifier: 05050474579132
• UDI-Public: (01)05050474579132(17)230628
• 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): 09/21/2020

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: 06/28/2023
• Device Model Number: ZXR00
• Device Catalogue Number: ZXR00U0220
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/13/2020
• Supplement Date Received by Manufacturer: 09/21/2020
• Initial Report FDA Received Date: 09/17/2020
• Supplement Report FDA Received Date: 09/21/2020
• 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
• Patient Age: 63 YR