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

Model Number	EMERALDT
Medical Device Problem Codes	Break (1069); Scratched Material (3020); Appropriate Device Problem Term/Code Not Available (3191); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the emerald injector broke the haptics, scratched and tore the intraocular lens (iol).The procedure was successfully completed with a backup lens.Reportedly, the iol was likely discarded.However the injector will be returned.No further information was provided.
Additional Manufacturer Narrative
Section a2, a4, a5, patient information: information unknown/not provided.Section b3, date of event: information unknown/not provided.Section d6a.If implanted, give date: not applicable as this is not an implantable device.Section d6b, if explanted, give date: not applicable as this is not an explantable device.Section h4, device manufacture date: unknown/not provided.Section h3-other (81): the device has not been returned for evaluation.Therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record, complaint trending, and risk documentation for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.Section h6, medical device problem code: 3191, this code was used for dissatisfaction - quality/design issue with the device.An attempt was made to obtain the missing information.However, it was not provided.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: section d9.Device available for evaluation? yes.Returned to manufacturer on: may 30, 2023, section h3.Device evaluated manufacturer? yes.Device evaluation: devices (handpieces) were returned, and no visual or functional defects were observed.Risk analysis was performed, and risk was determined to be low, with minimal consequences and the risk likelihood determined as unlikely to occur.A device history record review was performed with no evidence of nonconformance.The concomitant product iols were discarded by the customer and were not returned.The reported damage to the lenses could not be evaluated.Conclusion: as a result of the investigation there is no indication of a product quality deficiency, and the reported issue could not be verified.Please note that the information reported in sections d2 (common device name), h.6 (health effect -clinical code and medical device problem code) and section g.1 (manufacturer contact e-mail) is information that remain unchanged from the initial emdr report.All pertinent information available to johnson & 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.; 31 technology drive; irvine CA 92618
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 16829367
• Report Number: 3012236936-2023-00994
• Device Sequence Number: 7180402
• Product Code: KYB
• UDI-Device Identifier: 15050474500126
• UDI-Public: (01)15050474500126(17)120902(10)2-122
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2023

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 Expiration Date: 09/02/2012
• Device Model Number: EMERALDT
• Device Catalogue Number: EMERALDT
• Device Lot Number: 2-122
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 04/04/2023
• Supplement Date Received by Manufacturer: 06/13/2023
• Initial Report FDA Received Date: 04/28/2023
• Supplement Report FDA Received Date: 06/16/2023
• 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