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	Therapeutic Effects, Unexpected (2099); No Code Available (3191)
Date of Event	09/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Initial reporter address: unknown, information not provided.Initial reporter phone number: unknown, information not provided.(b)(4).Attempts have been made to obtain missing information; however, to date, no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the intraocular lens (iol) was explanted from a patient's left eye due to post-operative refractive surprise.The patient was post-lasik.The replacement lens is the same model, diopter power was not provided.It was indicated that the symptom onset was day one.The patient has recovered, and post-exchange, uncorrected visual acuity (ucva) was reported to be 20/20, and the patient is happy.No further information was provided.
Additional Manufacturer Narrative
Section d10.Device available for evaluation? yes.Returned to manufacturer on: 1/26/2021.Section h3.Device returned to manufacturer? yes.Device evaluation: the complaint lens was received in a specimen cup at the manufacturing site.Visual inspection under magnification revealed, viscoelastic residue on the optic body and haptics.And that the lens was received cut in pieces.Which is consistent with a lens, that was handled during explant.Based on the return condition of the lens, no further product evaluation could be performed.The complaint issue could not be confirmed, and no product deficiency could be identified.All pertinent information available to johnson and johnson surgical vision has been submitted.
Additional Manufacturer Narrative
The following fields were updated accordingly, based on the new information received for the initial reporter: section e1: initial reporter address: (b)(6).Section e1: initial reporter phone number: (b)(6).Device evaluation: the product testing could not be performed, as the product was not returned for evaluation.The reported complaint cannot be confirmed.Manufacturing record review: the manufacturing process record was evaluated, and no deviation was found during process related to the complaint issue reported.The product was manufactured and released according to specifications.A search in complaint system revealed, two additional complaints for this production order number.However, these complaint issues reported are not related to the event reported in this case.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.

• 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: 11025501
• Report Number: 2648035-2020-00943
• Device Sequence Number: 3486852
• Product Code: POE
• UDI-Device Identifier: 05050474579033
• UDI-Public: (01)05050474579033(17)230724
• Combination Product (Y/N): Y
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/26/2021

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: 07/24/2023
• Device Model Number: ZXR00
• Device Catalogue Number: ZXR00U0170
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2021
• Initial Date Received by Manufacturer: 11/19/2020
• Supplement Date Received by Manufacturer: 12/17/2020; 02/19/2021
• Initial Report FDA Received Date: 12/17/2020
• Supplement Report FDA Received Date: 01/11/2021; 02/26/2021
• 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