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

Model Number	PREVUE C (+ 23 D)
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	11/20/2023
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.Posterior capsule rupture is indicated as a potential adverse event related to iol implantation, 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.Defect in the iol with a poor smoothness resulting in rupturing the posterior capsule.Capsular bag tear / rupture.Prevue lens caused posterior capsule tear upon insertion immediately.Product replaced with another lens immediately during surgery.Anterior vitrectomy was required.The iol was explanted intraoperatively.No permanent or negative impact on patient health expected.Current patient prognosis is good.Explantation date: (b)(6) 2023.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.The product was not returned and appearance check was not performed.No abnormalities were found in production and inspection records of the product.(serial no.: (b)(6); model: prevue c).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.Defect in the iol with a poor smoothness resulting in rupturing the posterior capsule.Capsular bag tear / rupture.Prevue lens caused posterior capsule tear upon insertion immediately.Product replaced with another lens immediately during surgery.Anterior vitrectomy was required.The iol was explanted intraoperatively.No permanent or negative impact on patient health expected.Current patient prognosis is good.Explantation date: on (b)(6) 2023 problem code: a051102 - sharp edges.

• Brand Name: PREVUE C
• 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: 20233584
• Report Number: 3006723646-2024-00106
• Device Sequence Number: 15494535
• Product Code: HQL
• UDI-Device Identifier: 10757770564214
• UDI-Public: 10757770564214
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2024

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: 11/30/2023
• Device Model Number: PREVUE C (+ 23 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: 09/05/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/16/2024
• Supplement Report FDA Received Date: 10/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/30/2020
• 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