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

Model Number	ZMB00
Medical Device Problem Codes	Break (1069); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/04/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If implanted; give date: n/a (not applicable).The intraocular lens was removed and replaced during the same procedure.If explanted; give date: n/a (not applicable).The intraocular lens was removed and replaced during the same procedure.(b)(4).Device evaluation: the product testing could not be performed as the product was not returned.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 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: 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 model zmb00 tecnis multifocal iol (intraocular lens) fell apart in patient's eye and had to be removed in pieces.An incision enlargement was performed.The doctor replaced it with the same size and model lens.There was no damage nor injury to the patient's eye.No additional information provided.
Additional Manufacturer Narrative
Device available for evaluation? yes.Returned to manufacturer on: 10/1/2018.Device returned to manufacturer? yes.Device evaluation: the original packaging was received at the manufacturing site for investigation.Visual inspection shows the lens case was received in open condition with no lens in it.Product testing could not be performed because the lens was not returned.The complaint cannot be confirmed.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 & JOHNSON SURGICAL VISION, INC.; santa ana CA 92705
• MDR Report Key: 7930321
• Report Number: 3011852734-2018-00177
• Device Sequence Number: 1914055
• Product Code: MFK
• UDI-Device Identifier: 05050474535695
• UDI-Public: (01)05050474535695(17)210712
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/03/2020
• 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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/12/2021
• Device Model Number: ZMB00
• Device Catalogue Number: ZMB00U0235
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2018
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 09/04/2018
• Supplement Date Received by Manufacturer: 10/25/2018; 10/25/2020
• Initial Report FDA Received Date: 10/03/2018
• Supplement Report FDA Received Date: 11/19/2018; 11/03/2020
• 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
• Patient Age: 76 YR
• Date Report Sent to FDA: 01/01/2005