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

Model Number	ZXT300
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Disturbances (2140); No Code Available (3191)
Date of Event	02/12/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The intraocular lens (iol) is not returning for evaluation; therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record, and complaint trending for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.(b)(4).All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a zxr00 intraocular lens (iol) was implanted in the patient's right (od) eye on (b)(6) 2019.It was later explanted on (b)(6) 2020 due to blurry vision, described by patient as "fuzzy." patient feels like she is looking through fluorescent lights.Patient complains of difficulty focusing and significant difficulty driving, especially at night and difficulty with depth perception, including going up and down stairs.Best corrected distance visual acuity (bcdva) prior to primary surgery cataract extraction (ce) od was 20/40-2.Uncorrected distance visual acuity (ucdva) post ce od 20/50 +2.Bcdva post ce od with manifest refraction 20/20.At one (1) day post iol exchange bcdva od 20/30-2.Vision has improved since, but the clinic has not been open to formally check patient's vision.However, the patient had a telehealth appointment on (b)(6) 2020 with an online vision check (20/20 uncorrected), this is only an approximate.Reportedly, patient is functioning well post iol exchange and is satisfied with postoperative outcome.The replacement lens is a non-toric symfony iol.The customer also indicated that the toric iol was sent to pathology and is not available for return to johnson and johnson at this time.No further information 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.
Additional Manufacturer Narrative
Corrected data: in the initial mdr, the following fields need correction; section d4, model was reported as zxr00.Catalog number and serial number were populated as zxr00u0165 and (b)(6).Udi# as(b)(4).Expiration date: 5/12/2022.Section h4: device manufacture date: 5/12/2017.Additional info: based on received new information, the following fields have been updated accordingly.Section d4: model# and catalog#: zxt300, zxt300u165.Section d4: serial number: (b)(6).Section d4: unique device identifier (udi #): (b)(4).Section d4: expiration date: 7/14/2021.Section h4: device manufacture date: 7/14/2016.Device evaluation: the product is unavailable for return at this time as the customer sent the lens to pathology.If product is received after initial closure, the ir and complaint file (if necessary) may be re-opened to complete the return investigation.The complaint issue reported could not be verified and no product deficiency could be identified.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.Historical data analysis: a search of complaints revealed no other complaints have been received for this production order number.Conclusion: as a result of the investigation there is no indication of a quality product deficiency and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.H3 other text : placeholder.

• 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: 9966097
• Report Number: 9614546-2020-00189
• Device Sequence Number: 3835900
• Product Code: POE
• UDI-Device Identifier: 05050474579026
• UDI-Public: (01)05050474579026(17)220512
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/30/2020
• 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: 07/14/2021
• Device Model Number: ZXT300
• Device Catalogue Number: ZXT300U165
• 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: 03/20/2020
• Supplement Date Received by Manufacturer: 04/23/2020; 10/25/2020
• Initial Report FDA Received Date: 04/15/2020
• Supplement Report FDA Received Date: 05/04/2020; 10/30/2020
• 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: 69 YR
• Date Report Sent to FDA: 01/01/2005