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

Model Number ISERT 250 (+19.00 OD)

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Dry Eye(s) (1814); Pain (1994); Increased Sensitivity (2065); Blurred Vision (2137)

Event Type  Injury  

Manufacturer Narrative

Hoya device will not be returned for evaluation.(b)(4).

Event 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
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): HOYA SURGICAL OPTICS, INC.; 15335 fairfield ranch road; suite 250; chino hills CA 91709
• Manufacturer (Section G): HOYA MEDICAL SINGAPORE PTE LTD; 455a jalan abmad ibrahim; singapore, singapore, 63993 9 SN; SN 639939 SN
• Manufacturer Contact: corina pierson ; 15335 fairfield ranch road; suite 250; chino hills, CA 91709 ; 9096803900
• MDR Report Key: 6635474
• MDR Text Key: 77394181
• Report Number: 3006723646-2017-00013
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 04547480480763
• UDI-Public: 04547480480763
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P080004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ISERT 250 (+19.00 OD)
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention