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

Model Number 250 (+21.00 D)

Device Problem Device Appears to Trigger Rejection (1524)

Patient Problem Uveitis (2122)

Event Date 02/12/2022

Event Type  Injury  

Event Description

Reported case of inflammation / uveitis in mexico.The iol was implanted on (b)(6) 2022.The inflammation was observed 13 days after the surgery - (b)(6) 2022.Patient was treated with steroids and antibiotics for 3 weeks and has recovered.(b)(6) 2022: manufacturer's date of awareness.(b)(6) 2022: authorized country representative assessed as a reportable event to cofepris by end of year.

Manufacturer Narrative

This initial emdr is being submitted to fda for this as a reportable event that occurred outside the usa.Uveitis 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).Manufacturer's codes for patient health effects (clinical and impact), and device problem and component have been entered in this report.Manufacturer's codes for investigation type, findings and conclusion are pending the completion of the product investigation.Once the investigation is completed, a follow-up report will be submitted to fda which will include the manufacturer's codes for investigation type, findings and conclusion.

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 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 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.: tbl714y3; model: 251).There were no abnormalities in the sterilization records of the lot.(er686) since there were no abnormalities in the sterilization record especially residual eo test result, biological indicator test result and endotoxin test, we assure these batches were sterilized appropriately.Despite repeated attempts to obtain additional information / clarifications regarding this event, it was not possible to determine the exact root cause due to the lack of a completed postoperative inflammation summary form (pois form) detailing the patient medical history - lab test results, specific medications and treatment dates.Therefore, 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 Description

Reported case of inflammation / uveitis in mexico the iol was implantedon (b)(6) 2022.The inflammation was observed 13 days after the surgery - (b)(6) 2022 patient was treated with steroids and antibiotics for 3 weeks and has recovered.(b)(6) 2022: manufacturer's date of awareness (b)(6) 2022: authorized country representative assessed as a reportable event to cofepris by end of year.

Manufacturer Narrative

This follow-up #2 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 follow-up #1 report.Corrected information: b5 - corrected model, serial number, and patient impact.D1 - corrected model.D4 - corrected serial number, expiration date, and udi number.D6b - corrected to add explantation date.H4 - corrected manufacture date.H10 - corrected serial number and lot number (as updated below).Additional information: g6 - type of report - noted as follow-up #2.H2 - type of follow-up - noted for corrected information and additional information.H6 - added codes for patient health impact - device explantation.The product was not returned to the manufacturer.An updated investigation was conducted for the corrected model and serial number, 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 no abnormalities in the sterilization records of the lot.(er480).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 Description

Reported case of inflammation / uveitis in mexico.The iol was implanted on (b)(6) 2022.The inflammation was observed 13 days after the surgery - (b)(6) 2022.Patient was treated with steroids and antibiotics for 3 weeks and has recovered.(b)(6) 2022: manufacturer's date of awareness.(b)(6) 2022: authorized country representative assessed as a reportable event to cofepris by end of year (b)(6) 2022: per corrected information received from distributor.Model corrected to 250.Serial number corrected to (b)(6).Additional patient impact: device explanted on (b)(6) 2022.

• Brand Name: 250
• Type of Device: 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: 14989069
• MDR Text Key: 295719535
• Report Number: 3006723646-2022-00114
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 04547480480800
• UDI-Public: 04547480480800
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: P080004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 250 (+21.00 D)
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/05/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/31/2021
• 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