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

Model Number	HOYA ISERT (+13.00 OD)
Health Effect - Clinical Codes	Eye Injury (1845); Excessive Tear Production (2235)
Date of Event	10/25/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Regarding this report, device evaluation is pending.When investigation is completed, a follow-up report will be submitted to the fda.
Event or Problem Description
Report stated after iol was inserted into the eye, when surgeon was "dialing" it into place, a rough edge on the iol caused a tear in posterior capsule.The lens was centered in capsule when patient left the or.The lens may need to be explanted in the future if it does not stay in place.Additional information received on november 11, 2016 indicated that the lens was explanted on (b)(6) 2016 and was replaced with another iol (ar-40).
Additional Manufacturer Narrative
Complaint evaluation details from qa (b)(4): s/n: (b)(4) as the complaint product was not received from customer, visual inspection was not performed and further information could not be provided.According to the customer, a tear in the posterior capsule due to a rough edge on the iol during iol insertion.No abnormalities were found in production and inspection records of the product.Root cause was not determined.From the investigation it is believed this issue is not product related.(b)(4).Product not returned.
Event or Problem Description
Report stated after iol was inserted into the eye, when surgeon was "dialing" it into place, a rough edge on the iol caused a tear in posterior capsule.The lens was centered in capsule when patient left the o.R.The lens may need to be explanted in the future if it does not stay in place.Additional information received on november 11, 2016 indicated that the lens was explanted on (b)(6) 2016 and was replaced with another iol (ar-40).

• 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: 6149220
• Report Number: 3006723646-2016-00024
• Device Sequence Number: 10939911
• Product Code: HQL
• UDI-Device Identifier: 04547480480640
• UDI-Public: 04547480480640
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• 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: distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2016

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: 04/30/2017
• Device Model Number: HOYA ISERT (+13.00 OD)
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/11/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/06/2016
• Supplement Report FDA Received Date: 01/06/2017
• 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: Required Intervention
• Patient Age: 48 YR