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

Model Number B1PC (+20.00 D)

Device Problem Sharp Edges (4013)

Patient Problem Capsular Bag Tear (2639)

Event Date 03/14/2023

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.It was reported: lens on field; posterior capsule break; could not use lens.Patient health not impacted; patient has recovered and is fine.

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: type of report - noted as follow-up #1.Type of follow-up - noted for additional information added codes for manufacturer's investigation: type; findings; and conclusion.The product and videos were not available for investigation.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: b1pc).From our investigation, we couldn't confirm the reported event.We assumed this eventwas not caused by our product quality.

Event Description

Intra-operative complications: posterior capsule rupture.It was reported: lens on field; posterior capsule break; could not use lens.Patient health not impacted; patient has recovered and is fine.

• Brand Name: B1PC
• 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: 17297392
• MDR Text Key: 319020875
• Report Number: 3006723646-2023-00092
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 00886158017202
• UDI-Public: 00886158017202
• 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: 12/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: B1PC (+20.00 D)
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/15/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/31/2022
• 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