MAUDE Adverse Event Report: HOYA SURGICAL OPTICS, INC. NY1-SP; INTRAOCULAR LENS

Model Number NY1-SP (+20.50 D)

Device Problems Failure to Fold (1255); Detachment of Device or Device Component (2907)

Patient Problem Failure of Implant (1924)

Event Date 03/30/2022

Event Type  Injury  

Manufacturer Narrative

This initial emdr is being submitted to fda for outside us like products reporting."injector malfunction" is indicated as a potential malfunction related to the injector system, as covered under the warnings section of the product's instructions for use (ifu).(b)(4).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.

Event Description

A injector knob / plunger detachment, clogging during insertion and a tucking failure-trailing haptic were reported.The lens was explanted and replaced with another lens immediately during surgery.The patient's health was not impacted according to the complaint information.

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: d9 - corrected to no.Additional information: g6 - type of report - noted as follow-up #1.H2 - type of follow-up - noted for corrected information and additional information.H3 - indicated not returned to manufacturer.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: ny1-sp).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

A injector knob / plunger detachment , clogging during insertion and a tucking failure-trailing haptic were reported.The lens was explanted and replaced with another lens immediately during surgery.The patient's health was not impacted according to the complaint information.

• Brand Name: NY1-SP
• Type of Device: 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: 14376487
• MDR Text Key: 291518068
• Report Number: 3006723646-2022-00077
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: RO
• 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: 04/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NY1-SP (+20.50 D)
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2021
• 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