MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. UNK_CARTRIDGE_EMERALD_UNKNOWN; LEN, GUIDE, INTRAOCULAR

Model Number	UNKNOWN
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a sensar intraocular lens (iol) had the haptic cut when the injector began to descend and displace in the cartridge.It was stated that the iol almost did not descend, and in the patient's eye, then the doctor noticed that only one haptic went in because the other one was cut.The doctor took another lens, and this time the second haptic came loose.The doctor then took a non johnson and johnson iol and that allowed him to inject the iol.There was no incision enlargement , vitrectomy, sutures done on any of the 3 suspect lenses.This mdr report pertains to the first suspect unknown emerald cartridge with concomitant ar40e, serial number (b)(6).The other suspect products mentioned are not reportable.
Additional Manufacturer Narrative
Section a4, a5: unknown/ not provided.Asku.Section d4: model number: unknown but compatible cartridge with suspect lens is emerald cartridge.Section d6a: if implanted; give date: n/a (not applicable).The cartridge is not an implantable device.Section e1: telephone number: (b)(6).Section h3-other (81): the device was not returned for evaluation and the serial number for this device is unknown/not provided; therefore, no further product investigation can be performed.Should any further relevant information become available a supplemental medwatch will be filed.Section h4: device manufacture date: unknown, as the serial number was not provided.Attempts have 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.
Additional Manufacturer Narrative
Corrected data: upon further review it was noted that the following have been missed in the initial report submitted.Hence, fields below updated accordingly: section h5:labeled for single use?: "yes" should have been marked.Section h6: component code: 4755.Section h8: usage of device: ¿initial use of device¿ should have been marked.Then text in section h10 in the initial report said: ¿section h3-other (81): the device was not returned for evaluation and the serial number for this device is unknown/not provided¿ ¿, when it should not say serial number instead should say lot number.Also, ¿section h4: device manufacture date: unknown, as the serial number was not provided.¿ when it should not say serial number instead should say lot number.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: UNK_CARTRIDGE_EMERALD_UNKNOWN
• Common Device Name: LEN, 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: 18637144
• Report Number: 3012236936-2024-00284
• Device Sequence Number: 7731840
• Product Code: KYB
• UDI-Device Identifier: 05050474548657
• UDI-Public: (01)(10)UNKNOWN
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2024

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 Model Number: UNKNOWN
• Device Catalogue Number: UNK-CARTRIDGE_EMERALD_UNKNOWN
• 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: 01/15/2024
• Supplement Date Received by Manufacturer: 05/10/2024
• Initial Report FDA Received Date: 02/03/2024
• Supplement Report FDA Received Date: 05/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Concomitant Medical Products and Therapy/Usage Dates: AR40E SN (B)(6).
• Patient Age: 68 YR
• Patient Sex: Female