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

Model Number	TMICL13.2
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Patient-Device Incompatibility (2682); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Iritis (1940); UGH (Uveitis Glaucoma Hyphema) Syndrome (4470)
Date of Event	01/20/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No similar complaint was reported for units within the same lot.(b)(4).
Event or Problem 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.
Additional 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).
Additional 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)
• Common Device Name: PHAKIC TORIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 11334451
• Report Number: 2023826-2021-00361
• Device Sequence Number: 793234
• Product Code: QCB
• UDI-Device Identifier: 00841542109031
• UDI-Public: 00841542109031
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 01/26/2021
• Supplement Date Received by Manufacturer: 02/16/2021; 04/13/2021
• Initial Report FDA Received Date: 02/16/2021
• Supplement Report FDA Received Date: 03/07/2021; 05/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 35 YR