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

Model Number	ZXR00
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown, not provided.Best estimate of date of event is between (b)(6) 2018 and (b)(6) 2020.Patient code 3191: explant all pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a customer recently explanted a symfony lens and replaced it with a model ar40 intraocular lens (iol), 19.0 diopter power.There was no complication from the exchange, and a suture was not used.The patient is doing well post exchange.The reason for the exchange was due to a film that formed on the front surface of the lens, sometime after the patient underwent a retina procedure, which was a good bit after the original cataract surgery.The doctor believes that the film is likely the result of a combination of the blood and air/gas that was used during the retina procedure.Patient is reported to be doing well.No other information was provided.
Additional Manufacturer Narrative
Additional information: section d10: device available for evaluation? yes.Returned to manufacturer on: 1/6/2021.Section h3: device returned to manufacturer? yes.Device evaluation: the foreign material (described as ¿film that formed on the front surface of the lens¿) was received, on the returned complaint lens.Visual inspection under magnification, revealed viscoelastic residue on the optic body and haptics.And that the lens was received cut in half.Which is consistent with a lens that was handled, during explant.The foreign material was forwarded to eag laboratories for further analysis.Per eag laboratories, fourier infrared spectroscopy (ftir) analysis: ftir was unable to reasonably identify the white substance.Ftir can only characterize organic species present at 5-10 wt%.Anything below this concentration may not be amenable to ftir analysis.Edx revealed, the presence of low levels of ca and s.The complaint issue was confirmed (presence of foreign material).However, because ftir analysis could not be performed, because of the return condition of the lens and foreign material.No spectrum was able to be obtained for comparison against the añasco manufacturing process ftir library.And therefore, it cannot be confirmed, if the issue is related to handling or manufacturing, because añasco has manufacturing controls in place to prevent the release of product with foreign material on it.And therefore, no product deficiency could be identified.Manufacturing record review: the manufacturing process record was evaluated and revealed, that there was no discrepancy found, during the review.The product was manufactured and released according to specifications.A search revealed, that no other complaints were received from this production order.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 & 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: 11085038
• Report Number: 9614546-2020-00540
• Device Sequence Number: 14123582
• Product Code: POE
• UDI-Device Identifier: 05050474579088
• UDI-Public: (01)05050474579088(17)221029
• Combination Product (Y/N): Y
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/29/2022
• Device Model Number: ZXR00
• Device Catalogue Number: ZXR00U0195
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2021
• Initial Date Received by Manufacturer: 11/30/2020
• Supplement Date Received by Manufacturer: 02/25/2021
• Initial Report FDA Received Date: 12/28/2020
• Supplement Report FDA Received Date: 03/17/2021
• 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