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

Model Number CC4204A

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Patient Involvement (2645)

Event Date 12/19/2019

Event Type  Injury  

Manufacturer Narrative

Brand name: collamer ultraviolet-absorbing posterior chamber single piece foldable intraocular lens.No similar complaint type events reported for units within the same lot.The lens was returned in liquid, in a lens vial.Visual inspection found that the haptic and optic were torn.(b)(4).

Event Description

The reporter states that before the surgeon injected a cc4204a intraocular lens, diopter +18.5, he "looked at the lens in the injector and noticed that something looked wrong so he ejected the lens outside the eye and the lens was torn." there was no patient contact with the lens.This occurred on (b)(6) 2019.

Manufacturer Narrative

H6-previous statement-lens work order search: no similar complaint type events reported for units within the same lot.H6-corrected statement-lens work order search: two similar complaint type events reported for units within the same lot.Claim#: (b)(4).

Manufacturer Narrative

Corrected data: h3- "delivery system was returned in lens box.Visual inspection found the plunger bent." should be in the initial mdr.Claim# (b)(4).

• Brand Name: SEE H10
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia, ca
• MDR Report Key: 9690225
• MDR Text Key: 190667019
• Report Number: 2023826-2020-00274
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 00841542102360
• UDI-Public: 00841542102360
• Combination Product (y/n): N
• PMA/PMN Number: P990013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 01/20/2020

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: Health Professional
• Device Expiration Date: 10/31/2020
• Device Model Number: CC4204A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2020
• Initial Date Manufacturer Received: 01/20/2020
• Initial Date FDA Received: 02/10/2020
• Supplement Dates Manufacturer Received: 02/14/2020; 01/21/2021
• Supplement Dates FDA Received: 03/03/2020; 02/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: INJECTION SYSTEM MODEL-NANOPOINT, LOT#-UNK
• Patient Age: 74 YR