MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. TECNIS 1-PIECE; MONOFOCAL IOLS

Model Number	ZCB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	04/23/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If explanted; give date: not applicable, the lens remains implanted.International phone: (b)(6).Device evaluation: the product testing could not be performed as the product was not returned as it remains implanted.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.There was no discrepancy found during the mrr (manufacturing record review).The manufacturing data confirms no process deviations that may lead to lens incorrect sterilization process that may be undetected by our control process.The product was manufactured and released according to the specifications.A search revealed that no other complaints were received from this production order.Sterility review: the sterilization records for this lot were reviewed and no deviations were found that could affect the sterility of the device.The product was processed according to requirements and met the specifications.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the product.Conclusion: based on the investigation results there is no indication of a product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the patient had an infection one (1) week after the implantation of aspherical intraocular lens (iol).Per account, the hospital self-checked the aseptic status in the operating room and used all surgical device and tools for bacterial sampling and culture.The hospital used two different model zcb00 lenses for culturing and performed swab.Initial bacteria culture report shows presence of bacteria.The patient is currently undergoing anti-infective treatment in other hospitals.Per follow-up information, the hospital has verbally communicated that after a series of retests, they did not find bacteria and there is no suspicion on iol product.They conducted investigation for positive bacterial test results and identified the results are not associated with johnson & johnson surgical vision products.There is no issue about product sterility and they resumed usage of the iol products.They declined to share further details of the case.Two (2) patients have recovered.No additional information provided.

• Brand Name: TECNIS 1-PIECE
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; santa ana CA 92705
• MDR Report Key: 7544967
• Report Number: 2648035-2018-00776
• Device Sequence Number: 10814252
• Product Code: HQL
• UDI-Device Identifier: 05050474531666
• UDI-Public: (01)05050474531666(17)200321
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/25/2018

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: Physician
• Device Expiration Date: 03/21/2020
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000175
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2018
• Initial Report FDA Received Date: 05/25/2018
• 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: 72