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

Model Number	EMERALDT
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Expiration date: unknown/has been requested from the third party manufacturer (tpm).Phone number: (b)(6).The device is not returning for evaluation as it was discarded by the account; therefore, a failure analysis of the complaint device cannot be completed.A review of the device record and complaint trending for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.An attempt has been made to obtain missing information; however, no definitive response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that slight stain had been found to attach on the upper side of the intraocular lens (iol) za9003, after the iol was implanted.Exchanging the lens had not been planned because there had been no health damage in the patient and the condition of the eye had been good.It was noted that there had been no stain at the optic of the iol when the iol was set.There was no patient injury.No other information was provided.This report pertains to suspect emeraldt handpiece.A separate report will be submitted for suspect emeraldc cartridge.
Additional Manufacturer Narrative
Additional information: new information received that suspect lens expiration date is july 19, 2023 field below updated: section d4: expiration date: jul.19, 2023.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Corrected data: upon further review it was noted that implant date and explant date were not explained in section h10 in initial report submitted, as not applicable in each of the appropriate sections.Therefore, this report is submitted to correct this.Section d6a: if implanted; give date: n/a (not applicable).The handpiece is not an implantable device.Section d6b: if explanted; give date: n/a (not applicable).The handpiece is not an implantable device.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: 15591671
• Report Number: 3012236936-2022-02584
• Device Sequence Number: 2315290
• Product Code: KYB
• UDI-Device Identifier: 15050474500126
• UDI-Public: (01)15050474500126(17)991231(10)21-028
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/21/2022

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 Expiration Date: 07/19/2023
• Device Model Number: EMERALDT
• Device Catalogue Number: EMERALDT
• Device Lot Number: 21-028
• 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: 09/29/2022
• Supplement Date Received by Manufacturer: 10/17/2022; 10/21/2022
• Initial Report FDA Received Date: 10/12/2022
• Supplement Report FDA Received Date: 10/17/2022; 10/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ZA9003
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian