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

Model Number VICMO 13.2

Device Problems Improper or Incorrect Procedure or Method (2017); Unintended Movement (3026)

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

Event Date 11/14/2020

Event Type  Injury  

Manufacturer Narrative

Weight: unk.Ethnicity: unk.Race: unk.This product is not marketed in the us.Claim# (b)(4).

Event Description

The reporter indicated that the surgeon implanted upside down a 13.2mm vicmo 13.2, -11.00 diopter, implantable collamer lens, into the patient's left eye (os) on (b)(6) 2020.There was patient contact (lens touched the eye) with no patient injury.The lens was removed during initial surgery on (b)(6) 2020.The problem was resolved.Cause of the event is reported as user error.Reportedly, "the lens was damaged when it was extracted.".

Manufacturer Narrative

H3: device evaluation: lens was returned in micro-centrifuge vial, with moisture, residue/debris on product.Visual inspection found optic and haptic torn.Claim# (b)(4).

Manufacturer Narrative

B5: the reporter indicated that the surgeon implanted a 13.2mm vticmo13.2, -17.00/3.5/087 (sphere/cylinder/axis), implantable collamer lens into the patient's left eye (os) on (b)(6) 2020.The lens was removed and replaced on (b)(6) 2020 for a shorter length lens due to excessive vault and significant reduction of irido-corneal angles.This resolved the problem.Cause of the event is reported as unknown # (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: 11065546
• MDR Text Key: 223614230
• Report Number: 2023826-2020-03090
• 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,Followup
• Report Date: 12/01/2020

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: VICMO 13.2
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2021
• Initial Date Manufacturer Received: 12/01/2020
• Initial Date FDA Received: 12/23/2020
• Supplement Dates Manufacturer Received: 07/16/2021; 09/15/2021
• Supplement Dates FDA Received: 08/05/2021; 09/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 30 YR