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

Model Number	ISERT 250 (+19.00 OD)
Health Effect - Clinical Codes	Dry Eye(s) (1814); Pain (1994); Increased Sensitivity (2065); Blurred Vision (2137)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Hoya device will not be returned for evaluation.(b)(4).
Event or Problem Description
Patient called regarding the vision in her left eye.She had a hoya lens implanted 5 months ago.The next day post-op she had severe pain in her eye and a giant blur.She had a yag in both eyes which helped the sensitivity to light but did not help the blur or the pain.She had a second opinion but her pain and blur issues still exist.Now the doctor says she has dry eye.He said she needs prescription glasses.The right eye was implanted first and she has 20/20 vision post-op.The serial number was not provided nor the date of event.

• 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: 6635474
• Report Number: 3006723646-2017-00013
• Device Sequence Number: 13538078
• Product Code: HQL
• UDI-Device Identifier: 04547480480763
• UDI-Public: 04547480480763
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 06/12/2017

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 Model Number: ISERT 250 (+19.00 OD)
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2017
• Initial Report FDA Received Date: 06/12/2017
• 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