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

Model Number	HOYA ISERT 251 (+22.00 D)
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This initial and final emdr report is being submitted to fda for outside us like products reporting.The product was returned to the manufacturer, and the product investigation was conducted, with results noted below.The iol was ejected out from the injector, and the main piece was not returned.One haptic was separated at the tip.The slider was completely advanced until it stopped.The rod was advanced to the nozzle.The nozzle was stretched from the slit.Trace of lubricant was found inside the injector.The dye test result showed the injector tip was properly coated.No abnormalities were found in production and inspection records of the product.(serial no.: (b)(4); model: 251).In addition, research in our complaint database for the same production lot indicated there were not any other complaints reported as haptic separation.The root cause of the event could not be determined.However, from our investigation, we believe this event was not caused by our product quality.Risk analysis was conducted on the product line and failure code is noted below.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 or Problem Description
Damaged haptic after implantation.Haptic tip was separated and stuck in injector during use.Intra-operative explantation, a new lens was implanted.

• Brand Name: HOYA ISERT 251
• 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: 11235921
• Report Number: 3006723646-2021-00002
• Device Sequence Number: 19890756
• Product Code: HQL
• UDI-Device Identifier: 04547480450339
• UDI-Public: 04547480450339
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: P080004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/01/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: HOYA ISERT 251 (+22.00 D)
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2020
• Initial Report FDA Received Date: 01/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention