MAUDE Adverse Event Report: HOYA SURGICAL OPTICS, INC. HOYA ISERT 251; INTRAOCULAR LENS

Model Number	ISERT 251 (+20.50 D)
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Vitreous Loss (2142); Capsular Bag Tear (2639); Vitrectomy (2643)
Date of Event	04/23/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Regarding this initial report, the customer has indicated that the device is not available for evaluation.Per the manufacturer's complaint investigation, the following was noted: since the product was not returned for the investigation, product investigation could not be performed.No abnormalities were found in production and inspection records of the product.Possible causes: exact root cause is not determined.From our investigation, we believe this issue is not product related.
Event or Problem Description
Initial complaint information received from distributor stated that: "the tech stated the capsule tore after the iol was implanted.The iol was then explanted and replaced with a different iol." additional information in the data collection form received from the distributor indicated that: "capsule tore when iol inserted.Surgeon then removed the iol, performed a vitrectomy, and inserted a different iol." "iol was removed/explanted - date: (b)(6) 2018".
Additional Manufacturer Narrative
Follow-up report #2 is being submitted to fda for the following reason: on (b)(6) 2018, additional information was received from distributor regarding patient final outcome, as noted below."additional information received stated that the patient was doing fine post lens exchange.Final reading was: distance vision (dv) without correction was 20/30; pinhole 20/20.Near vision (nv): j5., manifest refraction (mr) was -0.75; 20/20.
Additional Manufacturer Narrative
Follow-up report #1 is being submitted to fda for the following reasons: additional information not avaiable/included in initial report - findings from the manufacturer's product/complaint inestigation, as noted below: since the product was not returned for the investigation, product investigation could not be performed.No abnormalities were found in production and inspection records of the product.Possible causes: exact root cause is not determined.From our investigation, we believe this issue is not product related.Additional information not available/included in initial report - risk analysis conducted on the product line and failure code, as noted below.A review of the most recent complaint trending data indicates no significant trends have been identified at this time, and no capa is required as part of product evaluation.This event can now be considered closed.

• Brand Name: HOYA ISERT 251
• 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: 7542008
• Report Number: 3006723646-2018-00011
• Device Sequence Number: 1818074
• Product Code: HQL
• UDI-Device Identifier: 04547480450308
• UDI-Public: 04547480450308
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P080004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/26/2018

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: 12/31/2019
• Device Model Number: ISERT 251 (+20.50 D)
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/26/2018
• Supplement Date Received by Manufacturer: 04/26/2018; 04/26/2018
• Initial Report FDA Received Date: 05/24/2018
• Supplement Report FDA Received Date: 05/25/2018; 06/13/2018
• 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