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

Model Number	ZCB00
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age/date of birth: unknown/not provided.Gender/sex: unknown, information not provided.If implanted, give date: not applicable, as lens was removed/replaced in the initial surgery.If explanted, give date: not applicable, as lens was removed/replaced in the initial surgery.Phone number: (b)(6) all pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that after the intraocular lens (iol) was implanted into the patient¿s eye, the surgeon found white mold on the lens optic.The surgeon removed the iol from the patient¿s eye.No further information was reported.
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-0148919 and capa-010215.
Additional Manufacturer Narrative
Section d10.Device available for evaluation? yes; returned to manufacturer on: 7/7/2020 section h3.Device returned to manufacturer? yes.Device evaluation: the complaint lens was received in the original lens case.Additionally, the original folding carton, patient id card, implant notification card, dfu, patient stickers, and an opened inner pouch were received.Korean notes written by the customer on the folding carton were observed and translated and reads as: ¿non-conforming¿, ¿replaced due to non-conforming lens¿, and the name of the hospital.Visual inspection under magnification revealed a detached haptic, what appeared to be 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 removal and replacement.Furthermore, the two lens halves were observed to be received stuck together, however, it cannot be confirmed if this is due to handling or what appeared to be viscoelastic residue drying and sticking the two lenses together.Based on the return condition of the lens no further product evaluation could be performed.The lens was sent to an independent laboratories for further analysis of what appeared to be white viscoelastic residue, which may be the "white mold on the optic" as described by the customer.Independent laboratory analysis: ftir analysis indicates that the foreign material is consistent with sodium hyaluronate, which is consistent with the viscoelastic residue of johnson & johnson (jjsv) healon.The complaint issue could not be confirmed.Ftir analysis identified the foreign substance as sodium hyaluronate (evaporated jjsv healon), and therefore it cannot be determined if this issue is related to handling or manufacturing since the manufacturing site does not manufacture jjsv healon and 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 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 that no other complaints have been received for this production order number.Conclusion: as a result of the investigation there is no indication of a product quality deficiency.All pertinent information available to johnson and johnson surgical vision has been submitted.

• Brand Name: TECNIS 1-PIECE
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 10306293
• Report Number: 2648035-2020-00529
• Device Sequence Number: 16350055
• Product Code: HQL
• UDI-Device Identifier: 05050474531772
• UDI-Public: (01)05050474531772(17)240222
• Combination Product (Y/N): Y
• Initial Reporter Country: KR
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/29/2020
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/22/2024
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2020
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 06/23/2020
• Supplement Date Received by Manufacturer: 07/27/2020; 10/25/2020
• Initial Report FDA Received Date: 07/22/2020
• Supplement Report FDA Received Date: 08/20/2020; 10/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CARTRIDGE, LOT#: UNKNOWN; CARTRIDGE, LOT#: UNKNOWN
• Date Report Sent to FDA: 01/01/2005