MAUDE Adverse Event Report: HOYA SURGICAL OPTICS, INC. HOYA NC1-SP; INTRAOCULAR LENS

Model Number HOYA NC1-SP (+17.50 D)

Device Problem Misfocusing (1401)

Patient Problem Visual Impairment (2138)

Event Date 11/24/2021

Event Type  Injury  

Event Description

Implant date: (b)(6) 2021.Date of event: (b)(6) 2021.Reportedly, a refractive error (minus 3.00 dpt) was caused by a lens dislocation (anterior).This was noticed around 5 days after the intraocular lense (iol) nanex multisert (model nc1-sp, serial number (b)(4)) was implanted on (b)(6) 2021.According to the reporter, the device was explanted on (b)(6) 2021 and replaced during the same surgery.No permanent or negative impact on patient health is expected.

Manufacturer Narrative

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

Implant date: (b)(6) 2021; date of event: (b)(6) 2021.Reportedly, a refractive error (minus 3.00 dpt) was caused by a lens dislocation (anterior).This was noticed around 5 days after the intraocular lense (iol) nanex multisert (model nc1-sp, serial number (b)(6) was implanted on (b)(6) 2021.According to the reporter, the device was explanted on (b)(6) 2021 and replaced during the same surgery.No permanent or negative impact on patient health is expected.

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: h3 - device evaluated by manufacturer: corrected to yes.Portions of the product were returned to the manufacturer.The investigation was conducted, with the methods and results as noted below.The optic was cut during explantation and only part of the optic and one haptic were returned.The injector was not returned.No abnormalities were found in production and inspection records of the product.(serial no.: (b)(6) ; model: nc1-sp).In addition, research in our complaint database indicated there were not any similar events in the same production lot number.From our investigation, we couldn't confirm the reported event.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: HOYA NC1-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: 13237762
• MDR Text Key: 289000756
• Report Number: 3006723646-2022-00008
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: 12/17/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2024
• Device Model Number: HOYA NC1-SP (+17.50 D)
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/17/2021
• Initial Date FDA Received: 01/12/2022
• Supplement Dates Manufacturer Received: 12/17/2021
• Supplement Dates FDA Received: 01/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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