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	Optical Decentration (1360)
Health Effect - Clinical Codes	Capsular Bag Tear (2639); Vitrectomy (2643)
Date of Event	01/23/2020
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
According to nadia - oculoplastic fellow reported lens inferiorly displaced.Lens changed to ma60ac, 18.50d.Patient impact: vitrectomy, explantation.
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: b5 - event or problem - additional information regarding patient impacts and outcome.D10 - device available? - corrected to no.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: patient (additional impact); 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.(b)(6) ; polishing bottle no.P102; production lot no.Pt18023590; 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
According to (b)(6) - oculoplastic fellow reported lens inferiorly displaced.Lens changed to ma60ac, 18.50d.Patient impact: vitrectomy, explantation.Additional and updated information: the leading haptic seems to slice the capsule.Patient impact: intra-operative explantation, posterior capsule rupture remedial action taken by the healthcare facility: lens was explanted and replaced with another one.Patient outcome: the patient is doing well.

• 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: 9819394
• Report Number: 3006723646-2020-00004
• Device Sequence Number: 3068250
• Product Code: HQL
• UDI-Device Identifier: 04547480480763
• UDI-Public: 04547480480763
• 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): 03/03/2020

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: 09/30/2021
• Device Model Number: HOYA ISERT 250 (+20.00 D)
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/03/2020
• Supplement Date Received by Manufacturer: 03/03/2020
• Initial Report FDA Received Date: 03/11/2020
• 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