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

Model Number	TMICL
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age, sex, weight, ethnicity, race: unk.Date of event: unk.Implant date: unk.A lens work order search was performed.One similar complaints found.Claim # (b)(4).
Event or Problem Description
It was reported that a 12.6mm,tmicl12.6, -6.50/2.5/092 (sphere/cylinder/axis), implantable collamer lens was removed from the patients right eye (od) and replaced with a shorter length lens due to sizing.If additional information is received a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
Correction: d4 serial number: corrected from (b)(6) to (b)(6).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: 12530669
• Report Number: 2023826-2021-03715
• Device Sequence Number: 13728394
• Product Code: QCB
• UDI-Device Identifier: 00841542106382
• UDI-Public: 00841542106382
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2021

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: 06/30/2023
• Device Model Number: TMICL
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/24/2021
• Supplement Date Received by Manufacturer: 09/24/2021
• Initial Report FDA Received Date: 09/24/2021
• Supplement Report FDA Received Date: 09/24/2021
• 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