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

Model Number	HOYA ISERT 251 (+21.00 D)
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This initial and final emdr report is being submitted to fda for like products reporting.Parts of the device were returned to the manufacturer.The product complaint investigation was conducted, and the results are noted below: the lens was ejected out from the injector tip and was not returned.The slider and the rod could advance fully.The cartridge was deformed at the tip.Trace of lubricant was found inside the cartridge tip.No abnormalities were found in production and inspection records of the product.Exact root cause is not determined.From our investigation, we believe this issue is not product related.Risk analysis conducted on the product line and failure codes are noted below: a review of the most recent complaint trending data indicates no significant trends have been identified at this time, and no capa is required as part of product evaluation.
Event or Problem Description
Leading haptic did not fold properly and was trapped between plunger an the cartridge tip, so the haptic torn off.Lens had to be explanted (no patient impact).New lens was implanted.Second implantation went well without harming the patient.

• 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: 8278763
• Report Number: 3006723646-2019-00001
• Device Sequence Number: 11185356
• Product Code: HQL
• UDI-Device Identifier: 04547480450315
• UDI-Public: 04547480450315
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P080004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/12/2018

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: 04/30/2021
• Device Model Number: HOYA ISERT 251 (+21.00 D)
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1