MAUDE Adverse Event Report: HOYA SURGICAL OPTICS, INC. 255; INTRAOCULAR LENS

Model Number 255 (+ 20.00 D)

Device Problem Sharp Edges (4013)

Patient Problem Capsular Bag Tear (2639)

Event Date 06/27/2023

Event Type  Injury  

Event Description

Event occurred in japan.Cracked or deformed cartridge/tip; intra-operative complications; posterior capsule rupture the doctor implanted the iol though he felt the iol was pushed back during iol insertion.After iol implantation he noticed the posterior capsule rupture.The iol was not explanted but fixed outside the capsule.He also found the nozzle was broken severely after iol insertion.Second surgery intervention will be planned.

Manufacturer Narrative

This initial report and final report is being submitted to fda for a reportable event that occurred outside the usa.Portions of the product were returned to the manufacturer.The investigation was conducted, with the methods and results as noted below.No abnormalities were found in production and inspection records of the product.(serial no.: (b)(6); model: 255) in addition, we didn't receive any other similar complaints on the same manufacturing lot from other hospitals.(pt22075046).The dye test result showed the injector tip was properly coated.Proper coating allows the lens to advance.We could release a re-installed iol from the returned injector without any problems.The exact root cause of the event was not determined.However, we believe this event was not caused by our product quality.A review of the 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.

• Brand Name: 255
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): HOYA SURGICAL OPTICS, INC.; 110 progress; suite 175; irvine CA 92618
• Manufacturer (Section G): HOYA CORPORATION; 6-10-1 nishi shinjuku; shinjuku-ku; tokyo, 160-0 023; JA 160-0023
• Manufacturer Contact: goutham pendyala ; 110 progress; suite175; irvine, CA 92618 ; 9093896317
• MDR Report Key: 17566109
• MDR Text Key: 321361926
• Report Number: 3006723646-2023-00414
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P080004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 255 (+ 20.00 D)
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2023
• Date Manufacturer Received: 06/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2022
• 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