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

Model Number	ISERT 251 (+20.00 OD)
Health Effect - Clinical Code	Rupture (2208)
Date of Event	03/04/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Results of manufacturers final investigation: the lens was ejected out from the injector.The slider and the rod could advance partially due to it was very tight while advancing.Review of our production records showed no irregularities or abnormities during its manufacturing and/or inspection process.We also went through our complaint database to look for similar complaints and complaint rates, which also does not show any trend of concern.The exact cause in this case cannot be ascertained.Given the low occurrence rate for this complaint category, hoya will continue regular trending of this type of complaint according to our post-marketing surveillance process.Given that we found no similar case in our complaint data base, we continue our complaint trending and treat this as a single case.
Event or Problem Description
During the lens implantation step, the defective functioning of the device caused the posterior capsule rupture and the dislocation of the lens in the vitreous chamber.Patient outcome is unknown at this time.The lens was explanted and a ya-60bbr was implanted.

• 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: 5660360
• Report Number: 3006723646-2016-00014
• Device Sequence Number: 16188217
• Product Code: HQL
• UDI-Device Identifier: 04547480450292
• UDI-Public: 04547480450292
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: P080004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/16/2016

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: 04/30/2018
• Device Model Number: ISERT 251 (+20.00 OD)
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2016
• Initial Report FDA Received Date: 05/17/2016
• 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