MAUDE Adverse Event Report: JOHNSON AND JOHNSON SURGICAL VISION, INC. TECNIS 1 MULTIFOCAL; MULTIFOCAL IOLS

Model Number	ZKB00
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If implanted, give date: not applicable, no patient involvement.If explanted, give date: not applicable, no patient involvement.Attempt has been made to obtain additional information; however, to date a response has not been received.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
Reportedly, a mark or foreign object was seen on a zkb00 18.5 diopter intraocular lens (iol) optic under the microscope prior to insertion.There was no patient contact with the lens.No additional information was provided.
Additional Manufacturer Narrative
Device evaluation: the product testing could not be performed as the product was not returned.The reported complaint could not be verified.Manufacturing record review: the manufacturing records for the product was reviewed.The product was manufactured and released according to specifications.A search revealed that no similar complaints were received for this production order.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: 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.
Additional Manufacturer Narrative
Device available for evaluation: yes.Returned to manufacturer on: 12/7/2018.Device returned to manufacturer: yes.Device evaluation: the intraocular lens (iol) was returned to the manufacturing site, floating in the lens box.Visual inspection showed that the lens was contaminated, dust particles were present.This is expected as the lens was transported from a controlled environment during manufacturing to a non-sterile, non-environmental controlled area.No other anomalies where identified.The customer''s reported complaint was not verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
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.

• Brand Name: TECNIS 1 MULTIFOCAL
• Common Device Name: MULTIFOCAL IOLS
• Manufacturer (Section D): JOHNSON AND JOHNSON SURGICAL VISION, INC.; santa ana CA
• MDR Report Key: 8056361
• Report Number: 9614546-2018-01064
• Device Sequence Number: 1807050
• Product Code: MFK
• UDI-Device Identifier: 05050474560055
• UDI-Public: (01)05050474560055(17)220415
• Combination Product (Y/N): Y
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/04/2020
• 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: 04/15/2022
• Device Model Number: ZKB00
• Device Catalogue Number: ZKB00U0185
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2018
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 10/15/2018
• Supplement Date Received by Manufacturer: 11/23/2018; 01/27/2019; 10/25/2020
• Initial Report FDA Received Date: 11/09/2018
• Supplement Report FDA Received Date: 12/13/2018; 02/21/2019; 11/04/2020
• 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