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

Model Number	ZLB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Visual Disturbances (2140); No Code Available (3191)
Date of Event	04/23/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown as information was not provided.If implanted, give date: unknown as information was not provided.If explanted, give date: not applicable, explant planned but not yet confirmed.(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported zlb00 24.5 diopter intraocular lens (iol) was implanted into the patient¿s ocular dexter (right eye).It was reported the patient is experiencing severe light sensitivity, starbursts around lights, and is also having ghosting effects.Pre-operative visual acuity was reported as 20/25, post-operative visual acuity was 20/50, and lens explant is scheduled.No additional information was provided to johnson & johnson surgical vision.
Additional Manufacturer Narrative
Device available for evaluation: yes.Returned to manufacturer on: 09/11/2019.Device returned to manufacturer: yes.Device evaluation: the product was received in a lens case.Visual inspection with the unaided eye shows the product is cut in pieces, most probably to make explant possible.Considering the condition of the lens additional analysis is not possible.The complaint cannot be confirmed.Conclusion: as a result, of the investigation there is no indication of a product malfunction or product quality deficiency.The reported issue was not verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Based on updated information received the following fields have been corrected: through follow up, customer account provided additional information confirming there was no complications, such as capsular tear, no serious patient injury, and no suture(s).There was an incision enlargement and the zlb00 iol was replaced with a zcb00 24.0 diopter iol.Date of event: updated from unknown to (b)(6) 2019.If implanted, give date: updated from unknown to (b)(6) 2019.If explanted, give date: updated from unknown to (b)(6) 2019.Device evaluated by manufacturer: yes.Patient code 3191 ¿ incision enlargement.Device evaluation: product testing could not be performed because the product was not returned.A product quality deficiency could not be confirmed.The reported issue was not verified.Manufacturing records review: the manufacturing records for the product were reviewed, the product was manufactured and released according to specification.Historical data analysis: (do not edit) a search revealed that no similar complaints for this order number have been received.Conclusion: as a result, of the investigation there is no indication of a product malfunction or product quality deficiency.The reported issue 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 (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: 8787288
• Report Number: 9614546-2019-00609
• Device Sequence Number: 14043350
• Product Code: MFK
• UDI-Device Identifier: 05050474560765
• UDI-Public: (01)05050474560765(17)190429
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/12/2020
• 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: 04/29/2019
• Device Model Number: ZLB00
• Device Catalogue Number: ZLB00U0245
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2019
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 06/13/2019
• Supplement Date Received by Manufacturer: 07/31/2019; 12/04/2019; 10/25/2020
• Initial Report FDA Received Date: 07/12/2019
• Supplement Report FDA Received Date: 08/16/2019; 12/11/2019; 11/13/2020
• 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: 66 YR
• Date Report Sent to FDA: 01/01/2005