MAUDE Adverse Event Report: STAAR SURGICAL COMPANY SEE H-10; INTRAOCULAR LENS

Model Number CC4204A

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/20/2018

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: collamer ultraviolet-absorbing posterior chamber single piece foldable intraocular lens.The lens was returned dry, in lens vial.Visual inspection found a small piece of lens returned, the rest of the lens was missing.There was residue on the lens.(b)(4).

Event Description

The reporter indicated the surgeon was inserting a cc4204a collamer single piece lens, +22.5 diopter and noted the lens was torn.There was patient contact but no injury.The backup lens was implanted.The reporter indicated the surgeon stated the lens was loaded incorrectly and was due to a loading error.

• Brand Name: SEE H-10
• 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 ; 6263037902
• MDR Report Key: 7527867
• MDR Text Key: 108737448
• Report Number: 2023826-2018-00755
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 00841542102445
• UDI-Public: 00841542102445
• 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
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/23/2018

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: 10/31/2019
• Device Model Number: CC4204A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/23/2018
• Initial Date FDA Received: 05/18/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/22/2017
• 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