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

Model Number	TMICL13.2
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Work order search: no similar complaint was reported for units within the same lot.Claim # (b)(4).
Event or Problem Description
The reporter indicated the surgeon implanted a 13.2mm tmicl13.2 implantable collamer lens, -07.50/+1.0/071 (sphere/cylinder/axis), in the patients right eye (od) on (b)(6) 2021.The reporter indicated the surgeon plans to explant and exchange the lens for a shorter lens.The lens remained implanted.Additional information has been requested but none has been forthcoming.
Additional Manufacturer Narrative
H3: device evaluation: the lens was returned in liquid, in a specimen cup.Visual inspection found no visible damage to the lens.Claim # (b)(4).
Additional Manufacturer Narrative
The lens was explanted on (b)(6) 2021 due to excessive vaulting and significant reduction of irido-corneal angles.The lens was replaced with a shorter lens and the problem was resolved.The eye is quiet, open angles and patient is happy with outcome.H6: health impact- clinical code: 4581 - significant reduction of irido-corneal angles.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: 12132577
• Report Number: 2023826-2021-02385
• Device Sequence Number: 4428616
• Product Code: QCB
• UDI-Device Identifier: 00841542108669
• UDI-Public: 00841542108669
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 06/10/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: TMICL13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2021
• Initial Date Received by Manufacturer: 06/10/2021
• Supplement Date Received by Manufacturer: 10/01/2021; 10/07/2021
• Initial Report FDA Received Date: 07/07/2021
• Supplement Report FDA Received Date: 10/05/2021; 10/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 38 YR