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

Model Number B1PC (UNKNOWN D)

Device Problem Sharp Edges (4013)

Patient Problem Capsular Bag Tear (2639)

Event Date 08/22/2022

Event Type  Injury  

Manufacturer Narrative

This initial emdr is being submitted to fda for an event that occurred inside of the usa.Capsular rupture is indicated as a potential adverse event related to the iol, as covered under the adverse events section of the product's instructions for use (ifu).B1pc: pkg-19-388 00 i51-09-153.01_b1py, b1pc.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 Description

Event occured in us.Problem code(imdrf code): a051102 sharp edges.Intra-operative complications.Capsule rupture in surgery room directly after implantation.

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 serial number was not provided so the production and inspection records of the product could not be reviewed.(serial no.: unknown; model: b1pc).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.No capa is required as part of the product evaluation.

Event Description

Event occured in us.Problem code(imdrf code): a051102 sharp edges intra-operative complications.Capsule rupture in surgery room directly after implantation.

• Brand Name: B1PC
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): HOYA SURGICAL OPTICS, INC.; 110 progress; suite 175; irvine
• 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
• MDR Report Key: 17950887
• MDR Text Key: 325867352
• Report Number: 3006723646-2023-00442
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P080004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: B1PC (UNKNOWN D)
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/15/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other