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

Model Number	HOYA ISERT 250 (+20.00 D)
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	02/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This initial emdr is being submitted to fda for outside us like products reporting.Manufacturer's code for patient and device have been entered in this report.Manufacturer's codes for method, results and conclusion are pending for device return and product investigation.Once the investigation is completed, an follow-up report will be submitted to fda which will include the manufacturer's codes for method, results and conclusion.
Event or Problem Description
Edge of leading iol haptic seems to be sharp/irregular and has cut the inferior equator of the lens capsule during aspiration of viscoelastic at the end of the cataract surgery procedure.Iol appeared to be centred at conclusion of cataract surgery but review 1 week later shows the intraocular lens has decentered inferiorly, causing monocular diplopia and blurred vision.Explanation to patient and family that the intraocular lens implant has decentered inferiorly and needs to be exchanged.Manufacturer informed.Intraocular lens removal, anterior vitrectomy and sulcus intraocular lens implanted (b)(6) 2020.Procedure went smoothly.
Additional Manufacturer Narrative
This follow-up #1 emdr is being submitted to fda for outside us like products reporting.This report includes the following additional information not available / included in the initial report, and corrected information, in the following sections, as noted below: d10 - device available? - corrected to no g1-2 - manufacturing site - corrected address information g7 - type of report - indicates "follow-up #1" h2 - follow-up type - indicates "correction" and "additional information" h3 - other reason - corrected to "not returned" h6 - manufacturer's codes were added for: method; results; and conclusion the device was not returned to the manufacturer; therefore, the product investigation consisted of a review of the production and inspection records.The investigation findings are noted below: review of the production records of the product showed there were not any nonconformities and deviations from the specifications.Especially, we confirmed polishing process of the iol was properly performed.(model 250; serial no.Taj218p3; polishing bottle no.P023; production lot no.Pt19002690; inspection result: pass) risk analysis conducted on the product line and failure code is noted below: a review of the most recent complaint trending data indicates that no significant trends have been identified at this time, and no capa is required as part of the product evaluation.
Event or Problem Description
Edge of leading iol haptic seems to be sharp/irregular and has cut the inferior equator of the lens capsule during aspiration of viscoelastic at the end of the cataract surgery procedure.Iol appeared to be centred at conclusion of cataract surgery but review 1 week later shows the intraocular lens has decentred inferiorly, causing monocular diplopia and blurred vision.Explanation to patient and family that the intraocular lens implant has decentred inferiorly and needs to be exchanged.Manufacturer informed.Intraocular lens removal, anterior vitrectomy and sulcus intraocular lens implanted (b)(6) 2020.Procedure went smoothly.

• Brand Name: HOYA ISERT 250
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): HOYA SURGICAL OPTICS, INC.; 15335 fairfield ranch rd.; suite 250; chino hills, ca
• MDR Report Key: 9866575
• Report Number: 3006723646-2020-00002
• Device Sequence Number: 525045
• Product Code: HQL
• UDI-Device Identifier: 04547480480787
• UDI-Public: 04547480480787
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P080004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: HOYA ISERT 250 (+20.00 D)
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/12/2020
• Supplement Date Received by Manufacturer: 02/12/2020
• Initial Report FDA Received Date: 03/23/2020
• Supplement Report FDA Received Date: 07/23/2020
• 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