MAUDE Adverse Event Report: HOYA SURGICAL OPTICS, INC. B3PC; INTRAOCULAR LENS

Model Number	B3PC (+ 19.5 D)
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Event occurred in united states.Damaged optic after implantation.Cracked or broken optic (middle).The patient is currently stable.There was no harm to the patient.An irregular main wound occurred during the case, but it was sealed well with suture.The physician removed the bisected optic from the anterior chamber.There will be no ongoing treatment.Sutures will be removed when wound is stable.Iol was explanted on (b)(6) 2025.Problem code: a0404 - crack.
Additional Manufacturer Narrative
This initial emdr is being submitted to fda for an event that occurred in the usa.Optic damage is indicated as a potential malfunction related to the iol, as stated under the warnings section of the product's instructions for use (ifu).Regarding section h6 - manufacturer's codes for: type of investigation, findings, and conclusion are pending device return and completion of product investigation.Once the product investigation is completed, a follow-up report will be submitted to fda which will include the manufacturer's codes for type of investigation, findings, and conclusion.
Additional Manufacturer Narrative
This follow-up report #1 emdr is being submitted to fda for a reportable event that occurred inside the usa.The report includes corrected and additional information not available/included in the initial report.Corrected information: h6 - updated codes for manufacturer's investigation: type; findings; and conclusion.Additional information: g6 - type of report - noted as follow-up #1.H2 - type of follow-up - noted for additional information.The product was not returned to the manufacturer.The investigation was conducted, with the methods and results as noted below.We couldn't confirm the reported event because the iol was ejected out and low resolution of the provided picture.No abnormalities were found in production and inspection records of the product (serial no.: (b)(6); model: b3pc).From our investigation, we couldn't confirm the reported event.The exact root cause was not determined.However, based on the available information and our investigation, we believe this event was not caused by our product quality.A review of the most recent complaint trending data indicates that no significant trends have been identified at this time and no capa is required as part of the product evaluation.

• Brand Name: B3PC
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): HOYA SURGICAL OPTICS, INC.; 110 progress; suite 175; irvine CA 92618
• Manufacturer (Section G): HOYA MEDICAL SINGAPORE PTE LTD; 455a jalan ahmad ibrahim; singapore, singapore 63993 9; SN 639939
• Manufacturer Contact: heber enriquez ; 110 progress; suite 175; irvine, CA 92618 ; 9495946220
• MDR Report Key: 22446902
• Report Number: 3006723646-2025-00052
• Device Sequence Number: 12825034
• Product Code: HQL
• UDI-Device Identifier: 00886158015772
• UDI-Public: 00886158015772
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P080004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2025

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: 09/30/2025
• Device Model Number: B3PC (+ 19.5 D)
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/08/2025
• Supplement Report FDA Received Date: 08/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/30/2022
• 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: Unknown