MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. UNFOLDER EMERALD; EMERALDC30

Model Number EMERALDC30

Device Problems Break (1069); Device Difficult to Setup or Prepare (1487); Scratched Material (3020)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Section a2, a4 and a5: per regulation eu 2016/679 (general data protection regulation), patient identifiers were not collected or recorded and therefore are not available.Section b3 - date of event: unknown, as information was requested but not provided section d4 - catalog number: unknown, as product lot number was not provided.Section d4 - lot number: unknown/not provided section d4 - expiration date: unknown, as product lot number was not provided.Section d4 - udi number: unknown, as product lot number was not provided.Section d6a - implant date: not applicable.The cartridge is not an implantable device.Section d6b - explant date: not applicable.The cartridge is not an implantable device; therefore, not explanted.Section e1 - first name: unknown, as information was asked but it was not provided.Section e1 - email address: unknown/not provided, as information was asked but it was not provided.Section e1 - telephone number: (b)(6).Section h3 - other (81): the cartridge was not returned for evaluation and the lens remains implanted.Therefore, a failure analysis of the complaint device could not 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 and possible product return and evaluation, if there is any further relevant information a supplemental medwatch will be filed.Section h4 - device manufacture date: unknown, as product lot number was not provided.Attempts have been made to obtain the missing information.However, to date, no response has been received.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that a few non-preloaded intraocular lenses (iol) were difficult to be twisted out of the cartridges and small scratches appeared on the edge of the optics.The lenses were implanted.Through follow-up we learned that there is no more additional information available about the cases.No further details provided.

• Brand Name: UNFOLDER EMERALD
• Type of Device: EMERALDC30
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 18062301
• MDR Text Key: 327644630
• Report Number: 3012236936-2023-02662
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Public: (01)(10)UNKNOWN
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K961242
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EMERALDC30
• Device Catalogue Number: EMERALDC30
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1