MAUDE Adverse Event Report: STAAR SURGICAL COMPANY SEE H10; INTRAOCULAR LENS

Model Number	CC4204A
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical product: collamer ultraviolet-absorbing posterior chamber single piece foldable intraocular lens.No similar complaint type events were reported for units within the same lot.Lens was returned in liquid, in lens vial.Visual inspection found the lens in two pieces and pieces of haptic are missing.(b)(4).
Event or Problem Description
The reporter stated that there was an issue with the loading of a cc4204a, +21.5 diopter, intraocular lens and when the surgeon inspected the lens it was torn in two pieces.There was no patient contact and the backup lens was used with no issues.Cause of event was reported as unknown.

• Brand Name: SEE H10
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 8062523
• Report Number: 2023826-2018-01617
• Device Sequence Number: 2745463
• Product Code: HQL
• UDI-Device Identifier: 00841542102421
• UDI-Public: 00841542102421
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P990013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/18/2018

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: 12/31/2019
• Device Model Number: CC4204A
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2018
• Initial Report FDA Received Date: 11/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR