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

Model Number	ZLB00
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Blurred Vision (2137); Dizziness (2194); Halo (2227); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown, not provided, but the best estimate date is between 11/13/2019 and 1/7/2020.(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that an intraocular lens (iol), model zlb00 24.5 diopter was explanted from a patient's left eye (os) due to mechanical failure.It was indicated that the incision was enlarged and the iol was removed in one (1) piece.There was no sutures used and no vitrectomy was required.No patient injury was reported.No additional information was provided.
Additional Manufacturer Narrative
Additional information: additional information received indicated that the patient had symptoms of constant blurry vision at all focal points.A refraction was performed to see if prescription lenses would resolve the constant blur.The lenses did not help resolve the symptoms of blur.The patient also had symptoms of extreme glare and halos preventing her from feeling safe to drive during the day or at night.The patient also had symptoms of dizziness.It was confirmed that all of these symptoms have resolved since the implant exchange.The patient is very happy with the outcome.It was also reported that the mechanical failure symptoms reported were first reported on december 10, 2019.The following fields was updated accordingly: section b3.Date of event: (b)(6) 2019.Section h6: additional patient code: 2227 - halo.Section h6: additional patient code: 2137 - blurred vision.Section h6: additional patient code: 3191 - glare.Section d10.Device available for evaluation? yes; returned to manufacturer on: 1/30/2020 section h3.Device returned to manufacturer? yes.Device evaluation: the sample was returned in a lens case at the manufacturing site for evaluation.The product was inspected using a microscope with a 12x magnification.It can be seen that the lens is contaminated, dust particles are present.This is expected as the lens was transported from controlled environment during manufacturing to a non-sterile, non-environmental controlled area.Investigation of the return sample and the condition of the return sample do not suggest the dust particles are introduced during manufacturing.The complaint cannot be confirmed.Manufacturing record review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.A search in the complaint system revealed that no similar complaints were 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 & 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-(b)(4) and capa-010215.

• Brand Name: TECNIS 1 MULTIFOCAL
• Common Device Name: MULTIFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 9662313
• Report Number: 9614546-2020-00047
• Device Sequence Number: 3172040
• Product Code: MFK
• UDI-Device Identifier: 05050474560765
• UDI-Public: (01)05050474560765(17)220711
• 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
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• 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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/11/2022
• Device Model Number: ZLB00
• Device Catalogue Number: ZLB00U0245
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2020
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 01/07/2020
• Supplement Date Received by Manufacturer: 02/06/2020; 10/25/2020
• Initial Report FDA Received Date: 02/03/2020
• Supplement Report FDA Received Date: 03/05/2020; 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
• Date Report Sent to FDA: 01/01/2005