MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. UNK-CARTRIDGE_EMERALD; LENS, GUIDE, INTRAOCULAR

Model Number	UNK-CARTRIDGE_EMERALD
Medical Device Problem Codes	Break (1069); Mechanical Jam (2983); Ejection Problem (4009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section a2, a3a, a3b, a4, a5 and a6: unknown, information not provided.Section d6a: implant date: not applicable, as lens was not implanted in the initial surgery.Section d6b: explant date: not applicable, as lens was not implanted in the initial surgery.Section e1: establishment address: unknown/not provided.Section e1: email address: unknown/not provided section e1: initial reporter: telephone number: (b)(6).Section h3: the device was not returned for evaluation; therefore, a failure analysis of the complaint device cannot be completed.A review of records including device history and complaint trending will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.Three follow-up attempts were made but no response was provided.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported during implantation of an intraocular lens, the plunger became stuck within the cartridge, resulting in the trailing haptic being kinked.The lens was partially inserted and subsequently removed during the same procedure.The patient experienced temporary impairment.The patient pre-operative visual acuity value was 6/45 and post-operative visual acuity value was 6/15.There was a delay of a few minutes occurred in the procedure.Medication was prescribed to the patient.There were no other interventions.No further information was provided.
Additional Manufacturer Narrative
Correction report: suspect medical device was inadvertently provided as sensar iol in the initial report when it is supposed to be a concomitant device instead.The suspect medical device is the emerald cartridge in this reported event.The corrected fields are updated as following: section d1, brand name: partial information provided due to the unknown lot number.Section d2a: common device name: lens, guide, intraocular section d2b.Device product code: kyb section d4, model and catalog number: partial information provided due to the unknown lot number.Section d4, lot number: unknown/no information section d4, expiration date: unknown as the lot number was not provided.Section d4, unique identifier (udi) number: a partial udi was provided as the lot number is not available.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 implantable device.Section h6.Adverse event problem health effect - impact code: 4632 - prolonged surgery health effect - impact code: 4631 - more complex surgery health effect - impact code: 4644 - medication required device code: 4009 - ejection problem device code: 1069 - break all pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: UNK-CARTRIDGE_EMERALD
• Common Device Name: LENS, GUIDE, INTRAOCULAR
• 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: 24811519
• Report Number: 3012236936-2026-000077
• Device Sequence Number: 9594159
• Product Code: KYB
• UDI-Device Identifier: 05050474502123
• UDI-Public: (01)(10)UNKNOWN
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: UNK-CARTRIDGE_EMERALD
• Device Catalogue Number: UNK-CARTRIDGE_EMERALD
• Device Lot Number: UNKNOWN
• 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: 03/16/2026
• Supplement Date Received by Manufacturer: 04/08/2026
• Initial Report FDA Received Date: 04/07/2026
• Supplement Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/07/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown