MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. UNFOLDER EMERALD; LENS, GUIDE, INTRAOCULAR

Model Number	EMERALDAR
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the surgeon tried to implant three (3) different 3-piece intraocular lenses (iol) using an emerald introducer and in all cases, haptics kept bending when introducing into the cartridge tip, prior to implantation.The surgeon assumes the introducer to be bent and faulty.The cartridge tip was in contact with the eye.The issue was first identified during implantation/ application.No further information was provided.This report pertains to the event which the lens was fully inserted in the patient's eye, then removed and replaced during the same procedure.Separate reports will be submitted for the other two events.
Additional Manufacturer Narrative
If implanted, give date: n/a (not applicable).The handpiece is not an implantable device.If explanted, give date: n/a (not applicable).The handpiece is not an implantable device; therefore, not explanted.Concomitant medical products: ar40e sensar lens, sn: (b)(4), emeraldc30 cartridge, lot: cj17494.(b)(6).Device manufacture date: unknown, as the lot number was not provided.The device has not returned for evaluation; therefore, a failure analysis of the complaint device cannot be completed.As the lot number is unknown no further investigation can be performed.If there is any relevant information received, a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Corrected information: section d4: model number: (b)(4).Section d4: lot number: 4-026.Section d4: udi #: (b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: section h3: device evaluated by manufacturer? yes.Device evaluation: photos of the device were reviewed by the external manufacturer.Parts were not returned for functional review, but photos supplied by the customer were reviewed by quality personnel with no reportable findings as the tip does not appear to be bent as initially reported.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

• Brand Name: UNFOLDER EMERALD
• Common Device Name: LENS, GUIDE, INTRAOCULAR
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 12997418
• Report Number: 3012236936-2021-00261
• Device Sequence Number: 5302109
• Product Code: KYB
• UDI-Device Identifier: 15050474500126
• UDI-Public: (01)15050474500126(10)UNKNOWN
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K961242
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/06/2022

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 Model Number: EMERALDAR
• Device Catalogue Number: EMERALDAR
• Device Lot Number: 4-026
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2021
• Supplement Date Received by Manufacturer: 12/15/2021; 03/18/2022
• Initial Report FDA Received Date: 12/14/2021
• Supplement Report FDA Received Date: 01/10/2022; 04/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown