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

Model Number	ZMB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Headache (1880); Pain (1994); No Code Available (3191)
Date of Event	07/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age/date of birth: unknown, information not provided.All pertinent information available to johnson and johnson surgical vision has been submitted.
Event or Problem Description
It was reported that tecnis multifocal intraocular lens (model zmb00 +16.5 diopter) was explanted from patient¿s left eye because of patient experiencing asthenopia, headaches, unexpected post op refraction of -2.50.Reportedly another lens, different model and lower diopter of 13.5 was used as the replacement lens.Patient has recovered.No further information provided.
Additional Manufacturer Narrative
Device available for evaluation, returned to manufacturer on: 1/21/2020.Device evaluation: the product was returned to the manufacturing site for evaluation.The sample was evaluated, and the lens was observed cut with residues that looks like body fluids and viscoelastic on the lens related to the handling of the unit in a surgical procedure.The condition observed is consistent with a lens that has been explanted.The reported issue was not verified.Based on the product returned evaluation, a product quality deficiency or product malfunction could not be determined.However, the lens diopter result obtained from the miq (measurement iol quality) electronic system of the test performed when this lens was manufactured, shows that lens serial number corresponded to 16.5 diopter as labeled; actual reading 16.46 d.Manufacturing record review: the manufacturing process record was evaluated and no deviation was found during process related to the complaint issue reported.The search revealed that no other complaint has been 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: 9572527
• Report Number: 2648035-2020-00037
• Device Sequence Number: 438880
• Product Code: MFK
• UDI-Device Identifier: 05050474535558
• UDI-Public: (01)05050474535558(17)220914
• Combination Product (Y/N): Y
• Initial Reporter State: KS
• 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: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/14/2022
• Device Model Number: ZMB00
• Device Catalogue Number: ZMB00U0165
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2020
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 12/17/2019
• Supplement Date Received by Manufacturer: 01/29/2020; 10/25/2020
• Initial Report FDA Received Date: 01/09/2020
• Supplement Report FDA Received Date: 02/03/2020; 11/04/2020
• 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