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

Model Number 255 (+21.00 D)

Device Problem Device Appears to Trigger Rejection (1524)

Patient Problem Endophthalmitis (1835)

Event Date 08/19/2022

Event Type  Injury  

Manufacturer Narrative

This initial report is being re-submitted (on a new emdr form) to fda for a reportable event that occurred outside the usa.(ref.Cesub ticket (b)(4))."endophthalmitis" 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).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 Description

Date of event: (b)(6) 2022.Date of surgery: not specified.Post-operative complication: endophthalmitis.The inflammation occurred around 1 week after cataract surgery.The symptoms were treated with medication of steroid and antibiotics and intravitreal injection of antibiotics.Va of the patient has recovered to 1.2.

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 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: 255).There were not any abnormalities on the sterilization records of the lot (tm017).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 Description

Date of event: 19-aug-2022.Date of surgery: not specified.Post-operative complication: endophthalmitis.The inflammation occurred around 1 week after cataract surgery.The symptoms were treated with medication of steroid and antibiotics and intravitreal injection of antibiotics.Va of the patient has recovered to 1.2.

• Brand Name: 255
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): HOYA SURGICAL OPTICS, INC.; 525 technology drive; suite 280; irvine CA 92618
• Manufacturer (Section G): HOYA CORPORATION; 6-10-1 nishi shinjuku; shinjuku-ku; tokyo, japan 160-0 023; JA 160-0023
• Manufacturer Contact: goutham pendyala ; 525 technology drive; suite 280; irvine, CA 92618 ; 9093896317
• MDR Report Key: 15601976
• MDR Text Key: 301724474
• Report Number: 3006723646-2022-00135
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P080004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 255 (+21.00 D)
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/23/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/31/2022
• 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