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

Model Number	250 (+19.00 D)
Medical Device Problem Code	Material Opacification (1426)
Health Effect - Clinical Codes	Failure of Implant (1924); Visual Impairment (2138); Eye Pain (4467)
Date of Event	03/11/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Implant date: (b)(6) 2022, date of event: 11 mar 2022, date pf explant: (b)(6) 2022.Event occurred in china.Manufacturer's date of awareness: (b)(6) 2022.Post-operative complications, cell adhesion.Optic opacification patient condition and symptoms: eye pain, visual impairment, failure of implant health impact: device explantation.
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.Regarding 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.
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: d3 - manufacturer's us address corrected to new location.G1 - manufacturer's us address corrected to new location.H3 - corrected to yes.Additional information: d9 - added date of product return.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.Portions of the product were returned to the manufacturer.The investigation was conducted, with the methods and results as noted below.The iol and picture and were available for investigation.Check result of the picture and appearance check result were consistent with the reported information.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.(er245) 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.
Event or Problem Description
Implant date: (b)(6) 2022.Date of event: 11 mar 2022.Date pf explant: (b)(6) 2022.Event occurred in china.Manufacturer's date of awareness: 17 may 2022.Post-operative complications, cell adhesion.Optic opacification.Patient condition and symptoms: eye pain, visual impairment, failure of implant.Health impact: device explantation.

• Brand Name: 250
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): HOYA SURGICAL OPTICS, INC.; 525 technology drive; suite 280; 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 ; 525 technology drive; suite 280; irvine, CA 92618 ; 9093896317
• MDR Report Key: 14712241
• Report Number: 3006723646-2022-00097
• Device Sequence Number: 16710257
• Product Code: HQL
• UDI-Device Identifier: 04547480480763
• UDI-Public: 04547480480763
• 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
• 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,Followup
• Report Date (Section B): 05/17/2022

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: 02/28/2024
• Device Model Number: 250 (+19.00 D)
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2022
• Supplement Date Received by Manufacturer: 05/17/2022
• Initial Report FDA Received Date: 06/16/2022
• Supplement Report FDA Received Date: 07/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2021
• 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