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 03/15/2023

Event Type  Injury  

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.

Event Description

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

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 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.Injector, iol and product information were not available for investigation.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.Will be re-assessed if additional information is received.

• 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: 17375974
• MDR Text Key: 319740239
• Report Number: 3006723646-2023-00430
• 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: 12/21/2023

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