MAUDE Adverse Event Report: HOYA SURGICAL OPTICS, INC. B1PY; INTRAOCULAR LENS

Model Number	B1PY (+25.00 D)
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Codes	Failure of Implant (1924); Capsular Bag Tear (2639)
Date of Event	03/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This initial emdr is being submitted to fda as a reportable event that occurred in the usa.Note: delayed emdr submission was due to fda esg webtrader account system software issues, per fda esg help desk ticket # (b)(4).Hoya due diligence is documented under internal (b)(4).Posterior capsule rupture is indicated as a potential adverse event related to iol implantation, as covered 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
Intra-operative complications posterior capsule rupture, explantation lens stuck to capular bag and tore thebag; caused surgeon to need toperform a vitrectomy.
Event or Problem Description
Intra-operative complications.Posterior capsule rupture, explantation.Lens stuck to capular bag and tore the bag; caused surgeon to need to perform a vitrectomy.
Additional Manufacturer Narrative
This follow-up #1 emdr is being submitted to fda for a reportable event that occurred inside of the usa.The report includes additional information not available/included in the initial report.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: b1py).The exact root cause of the event was not determined.However, based on available information, 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: B1PY
• 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: goutham pendyala ; 110 progress; suite 175; irvine, CA 92618 ; 9093896317
• MDR Report Key: 17015317
• Report Number: 3006723646-2023-00049
• Device Sequence Number: 12679779
• Product Code: HQL
• UDI-Device Identifier: 00886158017790
• UDI-Public: 00886158017790
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P080004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2023
• Device Model Number: B1PY (+25.00 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: 03/21/2023
• Supplement Date Received by Manufacturer: 03/21/2023
• Initial Report FDA Received Date: 05/26/2023
• Supplement Report FDA Received Date: 06/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2020
• 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