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

Model Number	ISERT 251 (+21.00 D)
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This initial emdr report is being submitted to fda for like products reporting.Once the investigation is completed, a follow-up report will be submitted to fda, which will include the manufacturer's codes for: method; results; and, conclusion.
Event or Problem Description
Realized there was a chip in the lens and cut it out of patients eye and put another in.New lens had to be implanted but without harming the patient.Patient impact: only lengthening of procedure.Patient outcome: no impact.
Additional Manufacturer Narrative
This follow-up report #1 is being filed for like products reporting - to submit corrected and additional information not available/included in the initial report.Section g7: type of report - indicated "follow-up #1".Section h2: type of follow-up - indicated "correction" and "additional information".Section h3: device evaluated - corrected to "yes".Section h6: event problem and evaluations codes: added codes for: method; results; and conclusion.Section h10: additional information: device evaluation and risk analysis results.The device was returned to the manufacturer.The product complaint investigation was conducted, and the results are noted below: the lens was cracked on the optic and one of the haptics was broken at the optic edge and ejected out from the injector tip.The slider and the rod could advance fully.Trace of lubricant was found inside the cartridge tip.No abnormalities were found in the production and inspection records of the product.Exact root cause could not be determined.From our investigation, we believe this issue is not product related.Risk analysis conducted on the product line and failure codes, 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.
Event or Problem Description
Realized there was a chip in the lens and cut it out of patients eye and put another in.New lens had to be implanted but without harming the patient.Patient impact: only lengthening of procedure.Patient outcome: no impact.

• Brand Name: HOYA ISERT 251
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): HOYA SURGICAL OPTICS, INC.; 15335 fairfield ranch rd.; suite 250; chino hills CA 91709
• MDR Report Key: 7985670
• Report Number: 3006723646-2018-00024
• Device Sequence Number: 221853
• Product Code: HQL
• UDI-Device Identifier: 04547480450315
• UDI-Public: 04547480450315
• 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: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2021
• Device Model Number: ISERT 251 (+21.00 D)
• Initial Date Received by Manufacturer: 10/12/2018
• Supplement Date Received by Manufacturer: 10/12/2018
• Initial Report FDA Received Date: 10/19/2018
• Supplement Report FDA Received Date: 11/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1