MAUDE Adverse Event Report: HOYA SURGICAL OPTICS, INC. HOYA ISERT 230; INTRAOCULAR LENS

Model Number	HOYA 230 ISERT (+22.50 OD)
Health Effect - Clinical Codes	Vitreous Loss (2142); Capsular Bag Tear (2639); Vitrectomy (2643)
Date of Event	01/31/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Regarding device evaluated by mfr? of this report, hoya device has not yet been returned.(b)(4).
Event or Problem Description
It was reported that the capsular bag was damaged during insertion of the lens in the patient's right eye.The haptic was damaged and in the physician opinion, the damage was due to "handling." reportability, the incision was enlarged to remove the lens and suture was needed.There was loss of vitreous and a vitrectomy was performed; however, because of too much bleeding and condition of the bag, no lens was implanted.Physician is evaluating treatment options.
Additional Manufacturer Narrative
Complaint evaluation details from b)(4): sn (b)(4).The lens was ejected out from the injector tip.The haptics were deformed.The entire injector was not returned, therefore visual inspection could not be performed and further information could not be provided.Trace of lubricant was found on the lens.Internal reference: (b)(4).
Event or Problem Description
It was reported that the capsular bag was damaged during insertion of the lens in the patient's right eye.The haptic was damaged and in the physician opinion, the damage was due to "handling." reportedly, the incision was enlarged to remove the lens and suture was needed.There was loss of vitreous and a vitrectomy was performed; however, because of too much bleeding and condition of the bag, no lens was implanted.Physician is evaluating treatment options.

• Brand Name: HOYA ISERT 230
• 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: 6378132
• Report Number: 3006723646-2017-00003
• Device Sequence Number: 10962119
• Product Code: HQL
• UDI-Device Identifier: 04547480301365
• UDI-Public: 04547480301365
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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
• Report Date (Section B): 02/14/2017

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: 07/31/2018
• Device Model Number: HOYA 230 ISERT (+22.50 OD)
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/09/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/03/2017
• Supplement Report FDA Received Date: 03/27/2017
• 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: 85 YR