MAUDE Adverse Event Report: HOYA SURGICAL OPTICS, INC. HOYA ISERT 250; INTRAOCULAR LENS

Model Number	ISERT 250 (+17.00 OD)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/11/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Hoya device has not yet been returned for evaluation.(b)(4).
Event or Problem Description
It was reported that the haptic ripped as the surgeon was advancing the lens into the eye.The incision was enlarged in order to remove the damaged lens.The back-up lens was then implanted with no issues.It was noted that a new technician prepared the lens for surgery.
Additional Manufacturer Narrative
This report, hoya device has not yet been returned for evaluation.(b)(4).Internal reference: (b)(4).
Event or Problem Description
It was reported that the haptic ripped as the surgeon was advancing the lens into the eye.The incision was enlarged in order to remove the damaged lens.The back-up lens was then implanted with no issues.It was noted that a new technician prepared the lens for surgery.
Additional Manufacturer Narrative
Complaint evaluation details from qa (b)(4): the lens was divided into a few pieces and ejected out from the injector tip.The leading and the trailing haptic were torn.The injector body was not returned.No abnormalities were found in production and inspection records of the product.Exact cause is not determined.From the investigation it is believed this issue is not product related.Internal reference: (b)(4).
Event or Problem Description
It was reported that the haptic ripped as the surgeon was advancing the lens into the eye.The incision was enlarged in order to remove the damaged lens.The back-up lens was then implanted with no issues.It was noted that a new technician prepared the lens for surgery.

• Brand Name: HOYA ISERT 250
• 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: 6557183
• Report Number: 3006723646-2017-00011
• Device Sequence Number: 995197
• Product Code: HQL
• UDI-Device Identifier: 04547480480725
• UDI-Public: 04547480480725
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P080004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/05/2017

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: 06/30/2019
• Device Model Number: ISERT 250 (+17.00 OD)
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/13/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 05/10/2017
• Supplement Report FDA Received Date: 05/12/2017; 06/05/2017
• 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: Other