MAUDE Adverse Event Report: HOYA SURGICAL OPTICS, INC. ISERT 230; INTRAOCULAR LENS

Model Number	ISERT 230 (+16.00 D)
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This initial emdr is being submitted to fda as a reportable malfunction that occurred in the usa.Haptic damage 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: type of investigation, findings, and conclusion are pending device return 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 or Problem Description
Broken haptic during use; haptic sheered off at haptic optic junction during insertion; device explantation - product replaced with another lens immediately during surgery; patient health not impacted; the lens never made it fully in the eye; no incision enlargement.
Event or Problem Description
Broken haptic during use; haptic sheered off at haptic optic junction during insertion; device explantation - product replaced with another lens immediately during surgery; patient health not impacted; the lens never made it fully in the eye; no incision enlargement.
Additional Manufacturer Narrative
This follow-up #1 emdr is being submitted to fda for a reportable malfunction that occurred in the usa.The report includes corrected information and additional information not available/included in the initial report.Corrected information: h3 - device evaluated: corrected to yes.The product was returned to the manufacturer.The investigation was conducted, with the methods and results as noted below.The appearance check result was consistent with the reported information.The dye test result showed the injector tip was properly coated.Proper coating allows the lens to move through the injector tip.We could release a re-installed iol from the returned injector tip without any problems.No abnormalities were found in production and inspection records of the product.(serial no.: (b)(6) ; model: 230).We also confirmed there were not any abnormalities on the loop pull strength test record of the material lot.(sosm-60-02) in addition, research in our complaint database indicated there were not any similar complaints in the same production lot.The exact root cause was not determined.However, 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: ISERT 230
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): HOYA SURGICAL OPTICS, INC.; 15335 fairfield ranch rd.; suite 250; chino hills CA 91709
• MDR Report Key: 12450603
• Report Number: 3006723646-2021-00068
• Device Sequence Number: 14348046
• Product Code: HQL
• UDI-Device Identifier: 04547480301235
• UDI-Public: 04547480301235
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: P080004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: ISERT 230 (+16.00 D)
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2021
• Initial Date Received by Manufacturer: 08/23/2021
• Supplement Date Received by Manufacturer: 08/23/2021
• Initial Report FDA Received Date: 09/09/2021
• Supplement Report FDA Received Date: 10/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1