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

Model Number	TMICL12.6
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Optical Problem (3001)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Disturbances (2140); Halo (2227)
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, -10.00/+1.5/093 (sphere/cylinder/axis), in the patients right eye (od) on (b)(6) 2020.The patient reported mild glare and halos at night.The lens remains implanted.This is the replacement lens for mfr.Report # 2023826-2020-02067.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: b5: the reporter indicated at the last visit the patient appeared to be still symptomatic for glare, halos and blurry vision.A 30 degree rotation of the lens was measured at last visit.Claim # (b)(4).
Additional Manufacturer Narrative
Corrected data: b5: the reporter indicated the surgeon implanted a 12.6mm tmicl12.6 implantable collamer lens, -10.00/+1.5/093 (sphere/cylinder/axis), in the patient's right eye (od) on (b)(6) 2020.The patient reported mild glare/halos at night and blurry vision.The lens remained implanted.At the post-op visit on (b)(6) 2020 the patient was doing well, expressed mild discomfort but didn't express any symptoms of glare/halos.This is the replacement lens for mfr.Report # 2023826-2020-02067.H6: medical device problem code: 2923 - this code was used in error, the lens did not rotate.Claim # (b)(4).
Additional Manufacturer Narrative
B5: the reporter indicated the surgeon implanted a 12.6mm tmicl 12.6 implantable collamer lens, -10.00/+1.5/093 (sphere/cylinder/axis), in the patients right eye (od) on (b)(6)2020.The patient reported mild glare and halos at night.The lens remains implanted.This is the replacement lens for mfr.Report#: 2023826-2020-02067.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: 10634467
• Report Number: 2023826-2020-02280
• Device Sequence Number: 16753739
• Product Code: QCB
• UDI-Device Identifier: 00841542106856
• UDI-Public: 00841542106856
• 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
• 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,Followup
• Report Date (Section B): 09/09/2020

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: 09/30/2020
• Device Model Number: TMICL12.6
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/09/2020
• Supplement Date Received by Manufacturer: 11/10/2020; 01/13/2021; 09/03/2021
• Initial Report FDA Received Date: 10/06/2020
• Supplement Report FDA Received Date: 12/13/2020; 06/01/2021; 09/03/2021
• 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: Other