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

Model Number	TMICL13.2
Medical Device Problem Codes	Misfocusing (1401); Optical Problem (3001)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Disturbances (2140); Halo (2227)
Type of Reportable Event	Malfunction
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, -14.50/+2.5/079 (sphere/cylinder/axis), in the patients right eye (od) on (b)(6) 2020.The patient reported glare/halos and blurred vision.The lens remains implanted.This lens was the replacement lens for mfr.Report # 2023826-2020-02066.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 reporter indicated at post-op visit on (b)(6) 2020, it showed the patient felt vision seemed better.At last visit on (b)(6) 2020, there were no complaints.Claim # (b)(4).
Additional Manufacturer Narrative
Corrected data: b3 - changed to product problem.B4 - "other serious or important medical events" should be removed as this claim should be corrected to non serious.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: 10634506
• Report Number: 2023826-2020-02282
• Device Sequence Number: 2438734
• Product Code: QCB
• UDI-Device Identifier: 00841542109673
• UDI-Public: 00841542109673
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 09/14/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2022
• Device Model Number: TMICL13.2
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/14/2020
• Supplement Date Received by Manufacturer: 11/24/2020; 06/21/2021
• Initial Report FDA Received Date: 10/06/2020
• Supplement Report FDA Received Date: 02/11/2021; 06/21/2021
• 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