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

Model Number	TMICL12.6
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cataract (1766)
Date of Event	04/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No similar complaint type events reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter states a 12.6mm tmicl12.6 implantable collamer lens -12.0/+1.5/109 (sphere/cylinder/axis) was implanted into the patient's right (od) eye on (b)(6) 2021.On (b)(6) 2021 the lens was explanted due to a posterior subcapsular cataract.Phaco-emulsification (cataract surgery) and iol implantation was performed.Moderate corneal edema and moderate anterior chamber cell are reported after explant.The cause of the event is reported as other: "while the mechanism of cataract formation remains speculative, the time course for the development of the cataract and the presence of anterior capsule findings in this case strongly suggest an association between the laser peripheral iridotomy and the posterior subcapsular cataract.".
Additional Manufacturer Narrative
B5-additional information: resolution date was 07-jun-2021.All symptoms returned to normal.(b)(4).
Additional Manufacturer Narrative
H3-device evaluation: the lens was returned in liquid in a micro-centrifuge vial.Visual inspection found no visible damage to the lens.Claim# (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS
• Common Device Name: PHAKIC TORIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 11894548
• Report Number: 2023826-2021-01709
• Device Sequence Number: 11671012
• Product Code: QCB
• UDI-Device Identifier: 00841542107136
• UDI-Public: 00841542107136
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/05/2021

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: 09/30/2022
• Device Model Number: TMICL12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2021
• Initial Date Received by Manufacturer: 05/05/2021
• Supplement Date Received by Manufacturer: 06/08/2021; 07/06/2021
• Initial Report FDA Received Date: 05/27/2021
• Supplement Report FDA Received Date: 07/05/2021; 07/31/2021
• 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: CARTRIDGE MODEL-SFC-45, LOT#-UNK; FOAM TIP PLUNGER MODEL-FTP, LOT#-UNK; CARTRIDGE MODEL-SFC-45, LOT#-UNK; FOAM TIP PLUNGER MODEL-FTP, LOT#-UNK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 26 YR