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

Model Number TMICL13.2

Device Problems Inadequacy of Device Shape and/or Size (1583); Patient-Device Incompatibility (2682); Device Dislodged or Dislocated (2923)

Patient Problems Iritis (1940); UGH (Uveitis Glaucoma Hyphema) Syndrome (4470)

Event Date 01/20/2021

Event Type  Injury  

Manufacturer Narrative

No similar complaint was reported for units within the same lot.(b)(4).

Event Description

The reporter indicated the surgeon implanted a 13.2mm tmicl13.2 implantable collamer lens, -10.00/+2.0/070 (sphere/cylinder/axis), in the patients right eye (od) on (b)(6) 2020.The lens was reported as having low vaulting, with lens rotation and patient experienced iritis.The plan is to explant and exchange the lens.Additional information has been requested but none has been forthcoming.If additional information is received, a supplemental medwatch will be submitted.

Manufacturer Narrative

B5: the lens was explanted on (b)(6) 2021.The patient had mild iritis/possible ugh (uveitis-glaucoma-hyphema), the lens was exchanged for a longer lens and the problem was resolved.Post-op, the eye is good and iop normal, icl stable, with no recurrence of iritis.Elected to exchange icl despite adequate vault due to icl rotation (60 degrees) and variable iop and post-op cell/flare.Increasing size appears to have solved the problem.The reporter indicated the cause of the event was patient related factor.Claim # (b)(4).

Manufacturer Narrative

H3: device evaluation: the lens was returned in liquid, in a vial.Visual inspection found one haptic torn.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: 11334451
• MDR Text Key: 232843643
• Report Number: 2023826-2021-00361
• Device Sequence Number: 1
• Product Code: QCB
• UDI-Device Identifier: 00841542109031
• UDI-Public: 00841542109031
• Combination Product (y/n): N
• PMA/PMN Number: P030016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/26/2021

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: 07/31/2022
• Device Model Number: TMICL13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2021
• Initial Date Manufacturer Received: 01/26/2021
• Initial Date FDA Received: 02/16/2021
• Supplement Dates Manufacturer Received: 02/16/2021; 04/13/2021
• Supplement Dates FDA Received: 03/07/2021; 05/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 35 YR