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

Model Number UNKNOWN MODEL

Device Problem Sharp Edges (4013)

Patient Problem Capsular Bag Tear (2639)

Event Date 11/22/2022

Event Type  Injury  

Event Description

Intra-operative complications: posterior capsule rupture.Patient condition and symptoms: capsular bag tear.Note: product model and diopter not provided.

Manufacturer Narrative

This initial emdr is being submitted to fda as a reportable event that occurred in the usa.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.

Manufacturer Narrative

This follow-up #1 emdr is being submitted to fda for an event that occurred inside of 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 and appearance check was not performed.Serial number and model information are not available, so risk assessment and trending cannot be performed.Complaint will be re-assessed if additional information is received.

Event Description

Intra-operative complications: posterior capsule rupture patient condition and symptoms: capsular bag tear note: product model and diopter not provided.

• Brand Name: UNKNOWN MODEL
• Type of Device: 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: 17375960
• MDR Text Key: 319742461
• Report Number: 3006723646-2023-00427
• 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: 11/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN MODEL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/22/2023
• 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