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

Model Number	HOYA 255 (+16.50 D)
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/02/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Date of implant : (b)(6) 2022.Damaged haptic after implantation.Haptic separation.Device was explanted.Patient impact: intra-operative explant.
Additional Manufacturer Narrative
This initial and final emdr is being submitted to fda for a reportable event that occurred outside the usa.Haptic damage is indicated as a potential malfunction related to the iol, 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 consistent to reported information.No abnormalities were found in production and inspection records of the product.(serial no.: (b)(4); 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 was not determined.However, based on our investigation, 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.
Event or Problem Description
Date of implant : (b)(6) 2022.Damaged haptic after implantation.Haptic separation.Device was explanted.Patient impact: intra-operative explant.
Additional Manufacturer Narrative
This initial and final emdr is being submitted to fda for a reportable event that occurred outside the usa.Haptic damage is indicated as a potential malfunction related to the iol, 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 consistent to reported information.No abnormalities were found in production and inspection records of the product.(serial no.: (b)(4); 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 was not determined.However, based on our investigation, 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: HOYA 255
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): HOYA SURGICAL OPTICS, INC.; 15335 fairfield ranch rd.; suite 250; chino hills CA 91709
• Manufacturer (Section G): HOYA CORPORATION; 6-10-1 nishi shinjuku; shinjuku-ku; tokyo, 160-0 023; JA 160-0023
• Manufacturer Contact: goutham pendyala ; 15335 fairfield ranch rd.; suite 250; chino hills, CA 91709 ; 9093896317
• MDR Report Key: 13581227
• Report Number: 3006723646-2022-00035
• Device Sequence Number: 14555343
• Product Code: HQL
• UDI-Device Identifier: 04547480301242
• UDI-Public: 04547480301242
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P080004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2024
• Device Model Number: HOYA 255 (+16.50 D)
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2022
• Initial Report FDA Received Date: 02/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/30/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown