MAUDE Adverse Event Report: HOYA SURGICAL OPTICS, INC. HOYA PC-60AD; INTRAOCULAR LENS

Model Number PC-60AD (+21.00 D)

Device Problem Break (1069)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 10/10/2018

Event Type  Injury  

Manufacturer Narrative

This initial emdr report is being submitted to fda for like products reporting.Regarding section of this report, the manufacturer's codes for method; result; and, conclusion are pending completion of the manufacturer's product/complaint investigation.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 Description

During the iol implantation the operator noticed the lens was broken, causing a damage of the posterior capsular bag; a new lens was implanted in the sulcus.

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 "device not evaluated" and "device not returned to manufacturer".Section h6 - event problem and evaluation codes: added codes for: method; results; and conclusion.Section h10 - additional information: device evaluation and risk analysis results.Device evaluation: the device was not returned to the manufacturer.Therefore, the product investigation consisted of a review of the production and inspection records.No abnormalities were found in the production and inspection records of the product.Exact root cause is not determined.From the investigation, it is believed that 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 Description

During the iol implantation the operator noticed the lens was broken, causing a damage of the posterior capular bag; a new lens was implanted in the sulcus.

• Brand Name: HOYA PC-60AD
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): HOYA SURGICAL OPTICS, INC.; 15335 fairfield ranch rd.; suite 250; chino hills CA 91709
• MDR Report Key: 8048875
• MDR Text Key: 126508343
• Report Number: 3006723646-2018-00025
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• PMA/PMN Number: P080004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 10/18/2018

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2020
• Device Model Number: PC-60AD (+21.00 D)
• Initial Date Manufacturer Received: 10/18/2018
• Initial Date FDA Received: 11/07/2018
• Supplement Dates Manufacturer Received: 10/18/2018
• Supplement Dates FDA Received: 01/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention