MAUDE Adverse Event Report: STAAR SURGICAL COMPANY IMPLANTABLE COLLAMER LENS (ICL); PHAKIC INTRAOCULAR LENS

Model Number VICM5_13.2

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Patient Involvement (2645)

Event Date 03/23/2020

Event Type  malfunction  

Manufacturer Narrative

This product is manufactured in the u.S.But not marketed in the u.S.No similar complaint was reported for units within the same lot.(b)(4).

Event Description

The reporter indicated the surgeon was loading a 13.2mm vicm5_13.2 implantable collamer lens, -08.00 diopter, and found the lens damaged.There was no patient contact.The surgeon implanted another same model/length/diopter lens and the problem was resolved.The cause of the event was unknown.

Manufacturer Narrative

Additional information: h3: device evaluation: lens returned in a micro-centrifuge vial with moisture on lens and clear surgical debris on product.Visual inspection found haptic torn and debris on lens.Claim#: (b)(4).

Manufacturer Narrative

Corrected data : h1- type of reportable event in previous mdr is corrected from serious to malfunction.Claim# : (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Type of Device: PHAKIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia, ca
• MDR Report Key: 9988436
• MDR Text Key: 192001495
• Report Number: 2023826-2020-00951
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup,Followup
• Report Date: 04/03/2020

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: 04/30/2022
• Device Model Number: VICM5_13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2020
• Initial Date Manufacturer Received: 04/03/2020
• Initial Date FDA Received: 04/22/2020
• Supplement Dates Manufacturer Received: 08/18/2020; 08/18/2020
• Supplement Dates FDA Received: 08/18/2020; 08/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 23 YR