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

Model Number VTICH

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

Patient Problems Cataract (1766); Capsular Bag Tear (2639); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The artical indicated that the surgeon implanted a vtich, implantable collamer lens into the patients right eye (od).Reporting that peripheral anterrior lens capusle damage and large peripheral iridectomy (pi) was observed with intraopterative pi during vtich implantaion.At 2 weeks post-op, ucva was 20/20.Both the traumatic cataract and large pi did not affect vision and patient is asymptomatic.Additional information has been requested but none has been forthcoming.If additional information is received a supplemental medwatch report will be submitted.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

An article indicated that a surgeon implanted a vtich implantable collamer lens into the patient's right eye (od).Intraoperative pi was performed.It was reported that the anterior lens capsule was damaged along with presence of traumatic cataract and low vault.A large pi was observed.Both the traumatic cataract and large pi did not affect vision and the patient is asymptomatic.Supposedly the lens remains implanted.(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: 8089155
• MDR Text Key: 127880958
• Report Number: 2023826-2018-01717
• 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: foreign,literature,other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/23/2018

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?: Yes
• Device Operator: Other
• Device Model Number: VTICH
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/23/2018
• Initial Date FDA Received: 11/20/2018
• Supplement Dates Manufacturer Received: 12/10/2018; 12/10/2018
• Supplement Dates FDA Received: 12/10/2018; 12/10/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other