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	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/31/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This initial and final emdr report is being submitted to fda for like products reporting.The device was returned to the manufacturer and a product investigation was conducted.The results are listed below.The lens was cracked and ejected out from the injector tip.One of the haptics was torn at near the blue tip.The slider could not advance completely.The rod could advance fully.The cartridge was cracked 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; however, from the investigation, it is believed 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 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
When the lens was inserted one of the haptics broke off, the lens was removed and replaced with another one.No patient impact.

• 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: 8484746
• Report Number: 3006723646-2019-00006
• Device Sequence Number: 1955526
• Product Code: HQL
• UDI-Device Identifier: 04547480450339
• UDI-Public: 04547480450339
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P080004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/06/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2021
• Device Model Number: HOYA ISERT 251 (+22.00 D)
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2019
• Initial Report FDA Received Date: 04/04/2019
• 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