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

Model Number	TMICL12.6
Medical Device Problem Code	Misfocusing (1401)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	09/08/2020
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 12.6mm tmicl12.6 implantable collamer lens, -09.50/+4.0/171 (sphere/cylinder/axis), in the patients right eye (od) on (b)(6) 2020.The lens was explanted on (b)(6) 2020 due to patient experienced poor visual acuity.The surgeon did not implant another icl 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
Additional data: h3: device evaluation: the lens was returned dry, in a specimen cup, with residue on lens.Visual inspection found no visible damage to the lens and there was residue on lens.Corrected data: b2: required intervention to prevent permanent impairment/damage.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: 10899956
• Report Number: 2023826-2020-02741
• Device Sequence Number: 19500899
• Product Code: QCB
• UDI-Device Identifier: 00841542106832
• UDI-Public: 00841542106832
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: 2020
• 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): 10/27/2020

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: 01/31/2022
• Device Model Number: TMICL12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2020
• Initial Date Received by Manufacturer: 10/27/2020
• Supplement Date Received by Manufacturer: 12/02/2020
• Initial Report FDA Received Date: 11/25/2020
• Supplement Report FDA Received Date: 01/07/2021
• 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