MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. EMERALD; SURGICAL ADJUNCTS

Model Number EMERALDC30

Device Problem Device Damaged by Another Device (2915)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Patient age/date of birth: unknown as information was not provided.Patient gender: unknown as information was not provided.Date of event: unknown as information was not provided.Unknown as product lot number was not provided.Device lot number: unknown as information was not provided.Udi number: a complete udi number is unknown as product lot number was not provided.If implanted: not applicable, as the cartridge is not an implantable device.If explanted: not applicable, as the cartridge is not an implantable device.The device was not returned for analysis as the product was discarded.Device lot number is not available; therefore, no further investigation can be performed.If there is any further relevant information received, a supplemental medwatch report will be filed.Device manufacture date: unknown, as product serial number was not provided.Device evaluation: product testing could not be performed because the product was not returned as it was destroyed.A product quality deficiency could not be confirmed.The reported issue was not verified.Manufacturing records review: the manufacturing record cannot be reviewed since product lot number is unknown.Historical data analysis: the complaint history was not reviewed since the product lot number is unknown.Conclusion: as a result of the investigation, considering the limited information available it cannot be determined if there is a product malfunction.The reported issue could not be verified as product was not returned.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported emerald cartridges are larger in size and maybe thicker when loaded into the inserter.Thus, causing a need for excessive force to advance the lens through the cartridge through the inserter; caused some scratches on the lenses.Three (03) boxes of cartridges were discarded due to this issue.Through follow-up, additional information was received confirming the lens was fully inserted.There was no unplanned incision enlargement, no serious patient injury, no unplanned suture(s), and no unplanned vitrectomy.The same procedure was successfully completed using back-up lens.Lens was implanted and is not being returned.Jjsv sales rep provided two (02) emerald cartridge lot numbers however service applications and products (sap) did not recognize the lot numbers provided.Emerald cartridge that were involved with the scratched lens are not available for return as they were discarded.No further information was provided.A separate report will be filed for the 1st suspect emerald cartridge.

Manufacturer Narrative

Additional information was received, and the following fields were updated accordingly: section d4: expiration date: updated from unknown to 19-may-2021; section d4: device lot number: updated from unknown to ch07742; section d4: udi number: updated from (b)(4) to (b)(4); section h4: manufacture date: updated from unknown to 19-may-2020.Device evaluation: product testing could not be performed, because the product was not returned as it was destroyed.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.Manufacturing records review: a search of complaints revealed, that one (01) additional complaint folder for this production order number, due to device code-difficult to use.Investigation results are pending.Therefore, there is no evidence of product deficiency.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.

Manufacturer Narrative

Additional information was received, and the following fields were updated accordingly: section d-10: device available for evaluation: yes section d-10: returned to manufacturer on: 21-feb-2021 section h-3: device returned to manufacturer: yes device evaluation: sample was received at amo puerto rico manufacturing/johnson and johnson surgical vision.Nineteen emeraldc30 cartridges were returned in their original package.All cartridges returned sealed and unused.No damaged and/or defects were observed on units that could impair the functionality of the device.The complaint issue reported was not verified.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.

• Brand Name: EMERALD
• Type of Device: SURGICAL ADJUNCTS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e. st. andrew place; santa ana CA 92705
• MDR Report Key: 10898541
• MDR Text Key: 234035104
• Report Number: 2648035-2020-00886
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 05050474530027
• UDI-Public: (01)05050474530027(10)UNKNOWN
• Combination Product (y/n): Y
• PMA/PMN Number: K961242
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 03/18/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 05/19/2021
• Device Model Number: EMERALDC30
• Device Catalogue Number: EMERALDC30
• Device Lot Number: CH07742
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2021
• Initial Date Manufacturer Received: 10/26/2020
• Initial Date FDA Received: 11/24/2020
• Supplement Dates Manufacturer Received: 12/15/2020; 02/27/2021
• Supplement Dates FDA Received: 01/10/2021; 03/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1