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

Model Number CC4204A

Device Problem Patient-Device Incompatibility (2682)

Patient Problem No Code Available (3191)

Event Date 05/28/2019

Event Type  Injury  

Manufacturer Narrative

Collamer ultraviolet-absorbing posterior chamber single piece foldable intraocular lens.(b)(4).

Event Description

The reporter indicated that a cc4204a, +23.00 diopter, intraocular lens was removed with no patient injury and replaced with another staar lens due to posterior vault.The reporter stated " equator to equator diameter is to small, caused lens to posterior vault".

Manufacturer Narrative

Device evaluation: lens was returned in liquid in a lens vial.Visual inspection found the haptic torn and the lens was returned in three pieces.Claim#: (b)(4).

• Brand Name: SEE H10
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 8731917
• MDR Text Key: 149114021
• Report Number: 2023826-2019-01115
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 00841542102452
• UDI-Public: 00841542102452
• Combination Product (y/n): N
• PMA/PMN Number: P990013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 05/29/2019

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• 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: 06/19/2019
• Initial Date Manufacturer Received: 05/29/2019
• Initial Date FDA Received: 06/25/2019
• Supplement Dates Manufacturer Received: 08/30/2019
• Supplement Dates FDA Received: 09/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR