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

Model Number	ZMA00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Corneal Edema (1791); Endophthalmitis (1835); Inflammation (1932)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown, not provided.Best estimate of date of event is (b)(6) 2019.If explanted, give date: not applicable, as lens remains implanted.(b)(4).Device evaluation: as the product was not returned for the evaluation, the complaint nor a product deficiency could be confirmed.Manufacturing record review: the manufacturing process record was evaluated and revealed that the product was manufactured according to specification.Review of the sterilization records shows there were no non conformance's with respect to the sterilization process.A search revealed that no similar 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.
Event or Problem Description
It was reported that the doctor noticed that four (4) patients had increased inflammation post-op.The doctor stated he was thinking it was due to toxic anterior segment syndrome (tass).The doctor did his own due diligence to see if there was a trend.He reviewed the surgeries to include any procedural changes, product changes or operating room changes.Nothing was found to be different.Lab cultures were not performed, nor any testing for tass.The patients had increased inflammation that did not subside, and a patient also had corneal edema.The doctor treated the patients with increased post-op medication with a change in dosage from the usual frequently to every hour instead.Patients were prescribed ofloxacin (antibiotic), prednisolone, and ketorolac (combination antibiotic, anti-inflammatory and steroid).The doctor noticed the patient¿s symptoms were subsiding.No plan to remove any of the lenses and thus far, all patients were ok.This mdr report pertains to the one of four events.A separate report will be submitted for the other lenses.
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-(b)(4) and capa-010215.

• Brand Name: TECNIS
• 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: 8746754
• Report Number: 2648035-2019-00675
• Device Sequence Number: 16516156
• Product Code: MFK
• UDI-Device Identifier: 05050474536784
• UDI-Public: (01)05050474536784(17)221023
• Combination Product (Y/N): Y
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P080010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2020
• 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: 10/23/2022
• Device Model Number: ZMA00
• Device Catalogue Number: ZMA00U0190
• 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: 06/03/2019
• Supplement Date Received by Manufacturer: 10/25/2020
• Initial Report FDA Received Date: 06/29/2019
• Supplement Report FDA Received Date: 11/13/2020
• 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