MAUDE Adverse Event Report: HOYA SURGICAL OPTICS, INC. MODEL 251; INTRAOCULAR LENS

Model Number	MODEL 251 (+19.50 D)
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/17/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This initial emdr is being submitted to fda for outside us like products reporting.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).Ifu not followed - it was noted that hpmc was used.The precautions section of the product's instructions for use (ifu) states: the lens has been validated with sodium hyaluronate ophthalmic viscosurgical devices (ovds); the use of other ovds and lubricants may cause damage to the lens and potential complications during implantation.Regarding section h6 - manufacturer's codes for: type of investigation, findings, and conclusion are pending 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 or Problem Description
Event occurred in germany.It was noted that hpmc was used.A broken haptic during use was reported.A secondary surgery required on future date.Patient impact: insufficient information.
Additional Manufacturer Narrative
Tthis follow-up #1 emdr is being submitted to fda for an event that occurred outside of the usa.The report includes additional information not available/included in the initial report.Additional information: g6 - type of report - noted as follow-up #1.H2 - type of follow-up - noted for additional information.H3 - indicated device not returned.H6 - added codes for manufacturer's investigation: type; findings; and conclusion.The product was not 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: 251).We also confirmed there were not any abnormalities on the loop pull strength test record of the material lot.(syvb-g115-11).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.Capa-23-0017 has been initiated for damaged haptics complaints.
Event or Problem Description
Event occurred in germany it was noted that hpmc was used.A broken haptic during use was reported.A secondary surgery required on future date; patient impact: insufficient information.

• Brand Name: MODEL 251
• Common Device Name: 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; suite175; irvine, CA 92618 ; 9093896317
• MDR Report Key: 17171883
• Report Number: 3006723646-2023-00096
• Device Sequence Number: 12562920
• Product Code: HQL
• UDI-Device Identifier: 04547480450285
• UDI-Public: 04547480450285
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P080004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2023

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: 03/31/2025
• Device Model Number: MODEL 251 (+19.50 D)
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2023
• Supplement Date Received by Manufacturer: 05/25/2023
• Initial Report FDA Received Date: 06/21/2023
• Supplement Report FDA Received Date: 08/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2022
• 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