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

Model Number 255 (+ 9.50 D)

Device Problem Sharp Edges (4013)

Patient Problem Capsular Bag Tear (2639)

Event Type  Injury  

Event Description

Intra-operative complications: capsule rupture.Date of surgery was not provided.The doctor stopped using the iol since it looked the capsule was ruptured when the leading haptic touched the capsule during iol insertion.He pulled back the nozzle from the incision, and the iol was not implanted.He used a cannula to push the iol back into theinjector.Patient impact: capsular bag rupture.

Manufacturer Narrative

This initial report is being submitted to fda for a reportable event that occurred outside the usa.Note: delayed emdr submission was due to fda esg webtrader account system software issues, per fda esg help desk ticket#: (b)(4) (and subsequent ticket#: (b)(6).Hoya due diligence is documented under internal: (b)(4).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).The product was returned to the manufacturer.The investigation was conducted, with the methods and results as noted below.Appearance check result was not consistent to reported information.The iol was not released and remained in the injector.We were unable to confi rm the event reported.No abnormalities were found in production and inspection records of the product.(serial no: (b)(6); model: 255).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, based on available information, we believe this event was not caused by our product quality.A review of the most recent 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: 17088058
• MDR Text Key: 316851067
• Report Number: 3006723646-2023-00077
• 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: 06/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 255 (+ 9.50 D)
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2023
• Date Manufacturer Received: 04/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2022
• 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