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

Model Number	HOYA 250 ISERT (+21.50 OD)
Health Effect - Clinical Code	Edema (1820)
Date of Event	12/14/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Please note that there was no way for us to confirm the validity of the complaint since the product has not been returned for evaluation at this time regarding device evaluated by mfr? part of this report, hoya device has not yet been returned.(b)(4).
Event or Problem Description
It was reported that the patient received hoya 250 lens on (b)(6) 2016 at outpatient surgical center in (b)(6).After 2 months, (b)(6) 2016 the surgeon removed the lens due to "power miss." on jan 13, 2017 hoya received information from b&l stating the surgeon believed the hoya iol was mislabeled.On (b)(6) 2016 the hoya lens was removed and replaced with a b&l li61ao model lens +18.5 diopter.On (b)(6) 2017 model li61ao +18.5 diopter lens was exchanged and surgeon believed a "power miss" and replaced with li61ao + 20.0 diopter.Also reported hoya lens nhr505r1 +21.5 was implanted on (b)(6) 2016 and a day after, on (b)(6) 2016 the patient developed myopic sight -4.00.The size of capsulorhexis was 5.L victus with intended target -2.00.Physician believes both hoya and b&l lenses were mislabeled and to be the most likely cause of the refractive error.The patient's current prognosis and treatment on (b)(6) 2017 (1 day post-op) is edema.
Additional Manufacturer Narrative
Please note that there was no way for us to confirm the validity of the complaint since the product has not been returned for evaluation at this time qa singapore evaluation: the product was not returned from the customer, therefore visual inspection could not be performed on the lens and further information could not be provided.(b)(4).
Event or Problem Description
It was reported that the patient received hoya 250 lens on (b)(6) 2016 at outpatient surgical center in (b)(6).After 2 months, (b)(6) 2016 the surgeon removed the lens due to "power miss." on jan 13, 2017 hoya received information from b and l stating the surgeon believed the hoya iol was mislabeled.On (b)(6) 2016 the hoya lens was removed and replaced with a b and l li61ao model lens +18.5 diopter.On (b)(6) 2017 model li61ao +18.5 diopter lens was exchanged and surgeon believed a "power miss" and replaced with li61ao + 20.0 diopter.Also reported hoya lens nhr505r1 +21.5 was implanted on (b)(6) 2016 and a day after, on (b)(6) 2016 the patient developed myopic sight -4.00.The size of capsulorhexis was 5.L victus with intended target -2.00.Physician believes both hoya and b&l lenses were mislabeled and to be the most likely cause of the refractive error.The patient's current prognosis and treatment on (b)(6) 2017 (1 day post-op) is edema.

• 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: 6294668
• Report Number: 3006723646-2017-00001
• Device Sequence Number: 13686149
• Product Code: HQL
• UDI-Device Identifier: 04547480480817
• UDI-Public: 04547480480817
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 01/09/2017

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: 05/31/2019
• Device Model Number: HOYA 250 ISERT (+21.50 OD)
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/09/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/01/2017
• Supplement Report FDA Received Date: 04/03/2017
• 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