MAUDE Adverse Event Report: HOYA SURGICAL OPTICS, INC. B1PC; INTRAOCULAR LENS

Model Number	B1PC (+ 22.5 D)
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	07/24/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This initial emdr is being submitted to fda for an event that occurred in the usa.Haptic 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.
Event or Problem Description
Event occurred in usa.Damaged haptic after implantation.Leading; root; haptics on device due to pc tear rupture during iol implantation.Broken haptic during use; leading haptic does not fold as per ifu.Haptic stuck tooptic temporarily~ finally haptic is separated.Capsular bag tear / rupture.Product remained in eye after clinical assessment; patient health not impacted.Patient has recovered and is fine; lens deployed as normal.Problem code: a051102 - sharp edges.
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 additional information not available/included in the initial report.Additional information: g6 - type of report - noted as follow-up #1 h2 - type of follow-up - noted for additional information h6 - added codes for manufacturer's investigation: type; findings; and conclusion.The product was not returned to the manufacturer.The investigation was conducted, with the methods and results as noted below.No abnormalities were found in production and inspection records of the product.(serial no.: (b)(6); model: b1pc).We also confirmed there were no abnormalities on the loop pull strength test record of the material lot.(sovg-g115-02) 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.
Event or Problem Description
Event occurred in usa.Damaged haptic after implantation.Leading; root; haptics on device due to pctearrupture during iol implantation.Broken haptic during use; leading haptic does not fold as per ifu.Haptic stuck tooptic temporarily~ finally haptic is separated.Capsular bag tear / rupture.Product remained in eye after clinical assessment; patient health not impacted.Patient has recovered and is fine; lens deployed as normal.Problem code: a051102 - sharp edges.

• Brand Name: B1PC
• 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
• MDR Report Key: 20185616
• Report Number: 3006723646-2024-00101
• Device Sequence Number: 8196274
• Product Code: HQL
• UDI-Device Identifier: 00886158017257
• UDI-Public: 00886158017257
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P080004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2024

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: 07/31/2025
• Device Model Number: B1PC (+ 22.5 D)
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/10/2024
• Supplement Report FDA Received Date: 10/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/31/2022
• 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
• Patient Sex: Unknown