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

Model Number	ISERT 251 (+16.50 OD)
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	02/03/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's preliminary analysis: this information was sent to our investigation laboratory for further investigation and requested to return the lens for investigation.Since the actual complaint rate is much lower than the alert level we will treat this as a normal complaint and wait until the outcome of the investigation before considering the need for further actions.The expected date of evaluation should be june, 2017.
Event or Problem Description
The lens was inserted into the patient's eye, where it was found to have a chunk missing from the iol.Patient outcome is unknown at this time.The lens had to be cut in two in order to remove it from the patient's eye, and another lens was inserted.
Additional Manufacturer Narrative
This follow-up #1 report is being submitted to fda based on updated information received after the completion of the product complaint investigation.Corrected and additional information are included in this follow-up #1 report, as noted below.Device available for evaluation? - corrected to "yes".Corrected to the current contact person's information.Report source - added "company representative".Type of report - indicated this is follow-up report, #1.Type of follow-up report - indicated: correction; and, additional information.Device evaluated by manufacturer? - corrected to "yes".Added manufacturer codes.Additional manufacturer narrative - information not available at the time of the initial report (for similar products marketed by the manufacturer), as follows: the device was returned to the manufacturer and a product investigation was conducted.As a part of the investigation, the production records were reviewed.No abnormalities were observed in the production or inspection records.In addition, the returned product was inspected.It was observed that a part of optic edge of trailing haptic side was chipped on the right side of the lens.The possibility of the pinch may have been caused by the slider pin inside injector due to the gap generated between slider pin and injector body and after advancement of iol by rod - with the optic pinched, the optic edge might be cracked or open.The exact root cause cannot be determined in this case.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 this product evaluation.

• Brand Name: HOYA ISERT 251
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): HOYA SURGICAL OPTICS, INC.; 15335 fairfield ranch road; suite 250; chino hills CA 91709
• MDR Report Key: 6483532
• Report Number: 3006723646-2017-00008
• Device Sequence Number: 981305
• Product Code: HQL
• UDI-Device Identifier: 04547480450223
• UDI-Public: 04547480450223
• 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: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2019
• Device Model Number: ISERT 251 (+16.50 OD)
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/23/2017
• Supplement Date Received by Manufacturer: 03/23/2017
• Initial Report FDA Received Date: 04/11/2017
• Supplement Report FDA Received Date: 07/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1