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

Model Number	HOYA 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	03/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This initial and final emdr is being submitted to fda for outside us like products reporting.The device was not returned to the manufacturer; therefore, the product investigation consisted of a review of the manufacturing records.The results are listed below: no abnormalities were found in production and inspection records of the product.Exact root cause is not determined.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
Both lenses were prepared correctly using adequate and correct amount of helaon.After injection and lens unfolding, chips were noticed missing from the optics.The lenses were not explanted as risk to the patient was considered higher if explanting rather than leaving in situ.No patient impact yet, but sharp edges of chips is concerning as could cause pc rupture as capsular bag shrinks.

• 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: 8817558
• Report Number: 3006723646-2019-00090
• Device Sequence Number: 11472796
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/12/2019

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: 11/30/2020
• Device Model Number: HOYA ISERT 251 (+21.00 D)
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2019
• Initial Report FDA Received Date: 07/23/2019
• 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: Other