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

Model Number	ZCB00
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age/date of birth: unknown/ not provided.Sex/gender: unknown/ not provided.If explanted; give date: not applicable as the lens remains implanted.(b)(6).Device evaluation: the product testing could not be performed as the lens remains implanted.The reported complaint could not be verified.A photo provided by the account was evaluated.A white spot was observed; however, due the photo resolution it is not possible to identify cause or the origin of the spot.A product quality deficiency could not be determined.Manufacturing records review: the manufacturing records for the product were reviewed.The review identified no non-conformance report associated to this production order number.The product was manufactured and released according to specification.The search revealed that no other complaint was 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.
Event or Problem Description
It was reported that after the surgeon implanted an intraocular lens (iol) model zcb00 into the patient¿s eye, a white spot was found on the center of lens.The surgeon tried to remove the spot but was unable to do so.The surgeon still completed the surgery and the patient does not feel any discomfort as a result of the white spot.Post-op visual acuity is not affected by the spot.The surgeon feels that the spot is in the body of the lens, and may try to verify this by slit-lamp exam on the patient's next visit.The account stated that this is the second time this event has occurred; however, they did not report the first incident until now.No additional information was provided.This emdr report pertains to the second event.A separate report will be submitted for the first event that the account encountered.
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.

• 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: 8932788
• Report Number: 2648035-2019-00921
• Device Sequence Number: 268840
• Product Code: HQL
• UDI-Device Identifier: 05050474531628
• UDI-Public: (01)05050474531628(17)220621
• Combination Product (Y/N): Y
• Initial Reporter Country: TW
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2020
• 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: 06/21/2022
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000155
• 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: 08/01/2019
• Supplement Date Received by Manufacturer: 10/25/2020
• Initial Report FDA Received Date: 08/26/2019
• Supplement Report FDA Received Date: 11/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005