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

Model Number VICM5_12.6

Device Problems Off-Label Use (1494); Scratched Material (3020)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/16/2020

Event Type  malfunction  

Manufacturer Narrative

Weight, ethnicity, race: unknown.Date recd by mfr-pma/510(k): this product is manufactured in the u.S.But not marketed in the u.S.(b)(4).Claim# (b)(4).

Event Description

The reporter indicated after opening a 12.6mm vicm5 12.6 implantable collamer lens, -10.5 diopter, and looking at it under the microscope, there was a scratch on the lens.There was no patient contact with the lens.

Manufacturer Narrative

H3 - device evaluation: lens was returned in a micro-centrifuge vial with residue and debris on the lens.Visual inspection found no visible damage and residue and debris on the lens.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 91016
• MDR Report Key: 11098618
• MDR Text Key: 226118164
• Report Number: 2023826-2020-03244
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 12/03/2020

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: 04/30/2023
• Device Model Number: VICM5_12.6
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2020
• Initial Date Manufacturer Received: 12/03/2020
• Initial Date FDA Received: 12/30/2020
• Supplement Dates Manufacturer Received: 02/28/2021
• Supplement Dates FDA Received: 03/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 18 YR