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

Model Number CC4204A

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Device name: collamer ultraviolet-absorbing posterior chamber single piece foldable intraocular lens.Work order search: no similar complaint type event reported for units within the same lot.(b)(4).

Event Description

The reporter indicated that prior to complete insertion of a cc4204a, +18.0 diopter, intraocular lens into the patient's eye it was noted that the trailing haptic was torn.There was no patient injury, no enlarge incision to remove the lens.Another lens was inserted to complete procedure and the patient was discharged without further incident.Cause of event was unknown.

• Brand Name: SEE H10
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer (Section G): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: cynthia thai ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 7444738
• MDR Text Key: 106015141
• Report Number: 2023826-2018-00570
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 00841542102353
• UDI-Public: 00841542102353
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P990013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/21/2018

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
• Device Operator: Physician
• Device Expiration Date: 04/30/2018
• Device Model Number: CC4204A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/21/2018
• Initial Date FDA Received: 04/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1