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

Model Number VICMO 12.1

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problems Not Applicable (3189); No Code Available (3191)

Event Date 06/06/2019

Event Type  Injury  

Manufacturer Narrative

This product is not marketed in the us.(b)(4).

Event Description

The reporter indicated that the surgeon implanted a 13.2mm, vicmo13.2, -8.50 diopter, implantable collamer lens into the patient's right eye (od) on (b)(6) 2019.On (b)(6) 2019 the lens was exchanged for a shorter length lens due to excessive vault.This exchange resolved the problem.

Manufacturer Narrative

Device evaluation: the lens was returned in a micro-centrifuge vial with moisture on the lens.Visual inspection found the haptic torn.Claim#: (b)(4).

Manufacturer Narrative

(b)(4).Patient code 3189 corrected to 3191.Patient code 3189 not applicable.

• 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: 8816881
• MDR Text Key: 151888914
• Report Number: 2023826-2019-01220
• 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: 06/28/2019

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: 02/28/2022
• Device Model Number: VICMO 12.1
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2019
• Initial Date Manufacturer Received: 06/28/2019
• Initial Date FDA Received: 07/23/2019
• Supplement Dates Manufacturer Received: 09/19/2019; 09/30/2019
• Supplement Dates FDA Received: 09/23/2019; 09/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 34 YR