MAUDE Adverse Event Report: HOYA SURGICAL OPTICS, INC. B1PY1950 - IPURE 1 PIECE PRELOADED INTRAOCULAR LENS (YELLOW), +19.50D; INTRAOCULAR LENS, PRODUCT CODE: HQL

Model Number	IPURE 1 PIECE PRELOADED INTRAOCULAR LENS (YELLOW), +19.50D
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/08/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Complaint reference (b)(4).Damaged haptic after implantation.Imdrf code: a0414, material split cut or torn.Leading haptic broke off upon insertion iol needed to be cutout of patients eye and another b1py was successfully implanted by the surgeon (b)(6) to the patient.Iol was explanted on (b)(6) 2023.

• Brand Name: B1PY1950 - IPURE 1 PIECE PRELOADED INTRAOCULAR LENS (YELLOW), +19.50D
• Common Device Name: INTRAOCULAR LENS, PRODUCT CODE: HQL
• Manufacturer (Section D): HOYA SURGICAL OPTICS, INC.; 110 progress; suite 175; irvine CA 92618 0333
• Manufacturer (Section G): HOYA SURGICAL OPTICS, INC; 110 progress; suite 175; irvine CA 92618 0333
• Manufacturer Contact: dhaval trivedi ; 500 totem pond road; 10 city point; waltham, MA 02451-1916
• MDR Report Key: 18476318
• Report Number: 1211998-2024-00001
• Device Sequence Number: 6885698
• Product Code: HQL
• UDI-Device Identifier: 00886158017684
• UDI-Public: 00886158017684
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/09/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2025
• Device Model Number: IPURE 1 PIECE PRELOADED INTRAOCULAR LENS (YELLOW), +19.50D
• Device Catalogue Number: B1PY1950
• Device Lot Number: 6DM90023
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2023
• Initial Report FDA Received Date: 01/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown