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

Model Number VTICH12.1

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Blurred Vision (2137); No Code Available (3191)

Event Date 10/06/2016

Event Type  malfunction  

Manufacturer Narrative

Work order search: no similar complaints were reported for units within the same lot.(b)(4).

Event Description

The reporter indicated a 12.1 mm vtich12.1 implantable collamer lens, +1.5/3/15 was implanted in patient's right eye on (b)(6) 2016.On (b)(6) 2017, the reporter indicated refractive surprise and lens rotation not associated with a low vault.The lens remains implanted in the patient.

Manufacturer Narrative

B2-corrected.B5-previously listed a sphere/cylinder/axis value of +1.5/3/15.Corrected value: +1.5/+3.5/015.Additional information reported: the patient "has a lot of pigmentation" on her icl surface and pigment dispersion.H6-patient code 3191: no code available (pigmentation on icl, pigment dispersion).Claim# (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: 6486516
• MDR Text Key: 72583019
• Report Number: 2023826-2017-00626
• 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
• Report Date: 11/28/2016

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: Physician
• Device Expiration Date: 10/31/2017
• Device Model Number: VTICH12.1
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/05/2017
• Initial Date FDA Received: 04/12/2017
• Supplement Dates Manufacturer Received: 01/29/2020
• Supplement Dates FDA Received: 02/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 30 YR