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

Model Number 251 (+20.50 D)

Device Problem Device Appears to Trigger Rejection (1524)

Patient Problem Toxic Anterior Segment Syndrome (TASS) (4469)

Event Date 10/20/2022

Event Type  Injury  

Event Description

Surgery date: (b)(6)2022.Date of event: (b)(6)2022.Post-operative complications inflammatory response after implantation toxic anterior segment syndrome (tass).

Manufacturer Narrative

This initial emdr is being submitted to fda for outside us like products reporting.Regarding manufacturer's codes for: type of investigation, findings, and conclusion are pending 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 Description

Surgery date: (b)(6)2022 date of event: 20-oct-2022 post-operative complications.Inflammatory response after implantation.Toxic anterior segment syndrome.(tass).

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.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 sterilization records of the lot.(es141) 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: 251
• 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: 15911712
• MDR Text Key: 304779769
• Report Number: 3006723646-2022-00160
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 04547480450308
• UDI-Public: 04547480450308
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 11/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 251 (+20.50 D)
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2022
• 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): Other