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

Model Number VTICMO13.2

Device Problems Inadequacy of Device Shape and/or Size (1583); Device Dislodged or Dislocated (2923); Optical Problem (3001)

Patient Problems Intraocular Pressure Increased (1937); Retinal Detachment (2047); Blurred Vision (2137); No Code Available (3191)

Event Date 06/15/2019

Event Type  Injury  

Manufacturer Narrative

Weight: unk.Ethnicity: unk.Race: unk.This product is not marketed in the us.(b)(4).Work order search: no similar complaint type events were reported for units within the same lot.(b)(4).

Event Description

The reporter indicated that a 13.2 vticmo, -18.00/1.0/091 (sphere/cylinder/axis), implantable collamer lens was implanted into the patients left eye (os) on (b)(6) 2019.Low vault with rotation, elevated iop, refractive surprise, and retina detachment was observed.Surgical intervention (repositioning, retinal repair and gas infusion) and medical intervention (antibiotics, steroids, glaucoma medication) were performed/ prescribed.Lens current status was reported to be in position but vault was approximately 100 microns.In the reporters opinion the cause of this event is unknown.Additional information has been requested but none has been forthcoming.If additional information is received a supplemental medwatch report will be submitted.

Manufacturer Narrative

Additional information received via email.The lens was repositioned a second time on (b)(6) 2019."patient has gas leakage in the eye.So again retina surgeon has gas filled up and they will wait for four week for visual recovery update." claim#: (b)(4).

Manufacturer Narrative

Corrected to state that the lens was implanted into the patient's left eye on (b)(6) 2019.(b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Type of Device: PHAKIC TORIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 9039904
• MDR Text Key: 158777163
• Report Number: 2023826-2019-01703
• Device Sequence Number: 1
• Product Code: QCB
• 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: 08/14/2019

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: 01/31/2022
• Device Model Number: VTICMO13.2
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/14/2019
• Initial Date FDA Received: 09/13/2019
• Supplement Dates Manufacturer Received: 09/27/2019; 11/22/2019
• Supplement Dates FDA Received: 10/25/2019; 11/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 20 YR