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

Model Number	TMICL12.1
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cataract (1766)
Type of Reportable Event	Serious Injury
Event or Problem Description
The reporter indicated the surgeon implanted a 12.1mm tmicl12.1 implantable collamer lens, -07.00/+1.0/092 (sphere/cylinder/axis), into the patients left eye (os) on (b)(6) 2021.It was reported at one week post-op, a small anterior cataract was observed.The patient is 20/15 ou and so far the cataract is a non issue.The lens remained implanted and the patient will be monitored.Additional information has been requested but none has been forthcoming.
Additional Manufacturer Narrative
Sex: unk; weight: unk; ethnicity: unk; race: unk; date of event: unk; explant date: unk.No similar complaint was reported for units within the same lot.Claim # (b)(4).
Additional Manufacturer Narrative
Sex: unk; weight: unk; ethnicity: unk; race: unk; date of event: unk; explant date: unk.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 12.1mm tmicl12.1 implantable collamer lens, -07.00/+1.0/092 (sphere/cylinder/axis), into the patients left eye (os) on (b)(6) 2021.It was reported at one week post-op, a small anterior cataract was observed.The patient is 20/15 ou and so far the cataract is a non issue.The lens remained implanted and the patient will be monitored.Additional information has been requested but none has been forthcoming.

• 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
• Manufacturer (Section G): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: cynthia thai ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 13082661
• Report Number: 2023826-2021-04920
• Device Sequence Number: 12095663
• Product Code: QCB
• UDI-Device Identifier: 00841542104258
• UDI-Public: 00841542104258
• 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: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/01/2021

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: 10/31/2022
• Device Model Number: TMICL12.1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2021
• Initial Report FDA Received Date: 12/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/18/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown