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

Model Number VTICMO13.2

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

Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)

Event Date 04/06/2018

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 13.2 mm vticmo13.2, -7.5/1.5/79 (sphere/cylinder/axis), implantable collamer lens into the patient's right eye (od) on (b)(6) 2018.On (b)(6) 2018 the lens was exchanged for a shorter lens due to observation of excessive vault.This exchange resolved the problem.

Manufacturer Narrative

The reporter indicated that the surgeon implanted a 13.2mm vticmo13.2 -7.50/1.5/079 (sphere/cylinder/axis) implantable collamer lens into the patient's right eye (od) on (b)(6) 2018.On (b)(6) 2018 the lens was removed due to excessive vault.Later, a new shorter lens was implanted on (b)(6) 2018.The problem was resolved.(b)(4)."lens was returned dry" not included in the supplemental mdr#1.(b)(4).

Manufacturer Narrative

Device evaluation: lens was returned in a micro-centrifuge vial.There was clear surgical residue on product.Visual inspection found no visible damage to the lens and presence of residue on lens surface.(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
• Manufacturer (Section G): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: cynthia thai ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 7855722
• MDR Text Key: 119541309
• Report Number: 2023826-2018-01354
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/08/2018

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: 12/31/2020
• Device Model Number: VTICMO13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/08/2018
• Initial Date FDA Received: 09/07/2018
• Supplement Dates Manufacturer Received: 10/09/2018; 11/01/2018
• Supplement Dates FDA Received: 10/31/2018; 11/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/05/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 21 YR