MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. UNFOLDER EMERALD; LENS, GUIDE, INTRAOCULAR

Model Number	EMERALDC30
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Codes	Eye Injury (1845); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/25/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an unfolder emerald cartridge has a bump in the plastic and cutting the patient's operative eye.The uneven cartridge tip was cutting the patient, the tip is uneven and not smooth.There was no medical or surgical intervention outside the standard of care required.The product was discarded.No further information provided.
Additional Manufacturer Narrative
Section a2: age/date of birth: unknown/not provided.Section d6a: if implanted; give date: n/a (not applicable).The cartridge is not an implantable device.Section d6b: if explanted; give date: n/a (not applicable).The cartridge is not an implantable device.(b)(6) section h3: the device was not returned for evaluation as it was discarded; therefore, a failure analysis of the complaint device cannot 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, if there is any further relevant information a supplemental medwatch will be filed.Section h6: health effect - clinical code: 4581 incision enlarged.Section h6: health effect - clinical code: 4625 incision enlarged.An attempt was made to obtain missing information; however, the account did not provide the information.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

• Brand Name: UNFOLDER 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: 19685210
• Report Number: 3012236936-2024-000184
• Device Sequence Number: 19636186
• Product Code: KYB
• UDI-Device Identifier: 05050474530027
• UDI-Public: (01)05050474530027(17)240714(10)CM21691
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K961242
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/05/2024

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 Expiration Date: 07/14/2024
• Device Model Number: EMERALDC30
• Device Catalogue Number: EMERALDC30
• Device Lot Number: CM21691
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2024
• Initial Report FDA Received Date: 07/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/14/2023
• 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: Required Intervention
• Patient Sex: Male
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White