MAUDE Adverse Event Report: HOYA SURGICAL OPTICS, INC. 250; INTRAOCULAR LENS

Model Number	250 (+23.50 D)
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Disturbances (2140)
Date of Event	03/18/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Implant date: (b)(6) 2022.Date of event: (b)(6) 2022.Event occurred in (b)(6).Manufacturer's date of awareness: 19 apr 2022.Inflammation; corneal edema, bulbar hyperemia, blurry vision, eye pain, cell adhesion.Patient condition and symptoms: visual distribances.Health impact: medication required.
Additional Manufacturer Narrative
This initial emdr is being submitted to fda for outside us like products reporting."adhesion of cells" is indicated as a potential adverse event related to iol implantation in hoya ifu covered under the warnings section.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 or Problem Description
Implant date: (b)(6) 2022.Date of event: 18 mar 2022.Event occurred in china.Manufacturer's date of awareness: 19 apr 2022.Inflammation; corneal edema, bulbar hyperemia, blurry vision, eye pain, cell adhesion.Patient condition and symptoms: visual disturbances.Health impact: medication required.
Additional Manufacturer Narrative
This follow-up #1 emdr is being submitted to fda for a reportable event that occurred outside of the usa.The report includes corrected information and additional information not available/included in the initial report.Corrected information: h3 - corrected to device not returned to manufacturer.Additional information: g6 - type of report - noted as follow-up #1.H2 - type of follow-up - noted for corrected information and additional information.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: 250).There were not any abnormalities on the sterilization records of the lot.(er484) pictures and post operative inflammation summary form (pois) were available for investigation.Based on a review of this information, this case is not bacterial endophthalmitis.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: 250
• 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 MEDICAL SINGAPORE PTE LTD; 455a jalan ahmad ibrahim; singapore, singapore 63993 9; SN 639939
• Manufacturer Contact: goutham pendyala ; 15335 fairfield ranch rd.; suite 250; chino hills, CA 91709 ; 9093896317
• MDR Report Key: 14418559
• Report Number: 3006723646-2022-00080
• Device Sequence Number: 5550979
• Product Code: HQL
• UDI-Device Identifier: 04547480480855
• UDI-Public: 04547480480855
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P080004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2024
• Device Model Number: 250 (+23.50 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: 04/19/2022
• Supplement Date Received by Manufacturer: 04/19/2022
• Initial Report FDA Received Date: 05/17/2022
• Supplement Report FDA Received Date: 06/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2021
• 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