MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. UNK_CARTRIDGE_EMERALD_UNKNOWN; UNFOLDER CARTRIDGE

Model Number	EMERALDC30
Medical Device Problem Codes	Difficult to Advance (2920); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Weight and ethnicity: unknown, information not provided.If implanted, give date: not applicable, as lens was removed/replaced in the initial surgery.If explanted, give date: not applicable, as lens was removed/replaced in the initial surgery.Device evaluation: product testing could not be performed since the product was not returned for evaluation.Therefore, the reported issue could not be verified, and product quality deficiency could not be determined.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.A search revealed that no additional complaint was received from this production order.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.
Event or Problem Description
It was reported that a ar40m model intraocular lens(iol) was partially inserted and got stuck in the cartridge.The iol had to be cut out during the same procedure.This event was observed while inserting the lens into the patient's eye.There was no patient injury and no medical/surgical interventions such as vitrectomy, incision enlargement or sutures were done.Procedure was completed successfully using backup lens of same model and diopter.Patient recovered fine after the surgery.No further information available.
Additional Manufacturer Narrative
Corrected data: upon further review it was noted that initial mdr report (2648035-2021-07692), was inadvertently submitted against the ar40m intraocular lens.However, per reported device code the correct reportable suspect product was the emeraldc cartridge.The following sections have been updated: section d1: brand name: unk_cartridge_emerald_unknown section d2: type of the device: common device name: unfolder cartridge section d2: type of the device: device product code: kyb section d4: model number: emerald c30 section d4: lot number: unknown/not provided section d4: unique id number: (b)(4).Unknown section d4: expiration date: unknown as the lot number was not provided.Section d6: if implanted; give date: n/a (not applicable).The cartridge is not an implantable device.Section d7: if explanted; give date: n/a (not applicable).The cartridge is not an implantable device.Section d10: concomitant product: ar40m, serial number (b)(6).Section h4: manufacture date: unknown as the lot number was not provided.Additional data: it was confirmed that the suspect cartridge has not been returned by the account.Section h3:81 - other: 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/lot history 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.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.See h10 for explanation.

• Brand Name: UNK_CARTRIDGE_EMERALD_UNKNOWN
• Common Device Name: UNFOLDER CARTRIDGE
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• MDR Report Key: 11742879
• Report Number: 2648035-2021-07692
• Device Sequence Number: 1389805
• Product Code: KYB
• UDI-Device Identifier: 05050474501805
• UDI-Public: (01)05050474501805(17)230828
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• 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 faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/28/2023
• Device Model Number: EMERALDC30
• Device Catalogue Number: EMERALDC30
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/30/2021
• Supplement Date Received by Manufacturer: 04/28/2021
• Initial Report FDA Received Date: 04/28/2021
• Supplement Report FDA Received Date: 05/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AR40M, SERIAL NUMBER (B)(6).; EMERALD INSERTER
• Patient Age: 47 YR