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

Model Number	TMICL13.2
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Corneal Edema (1791); Intraocular Pressure Increased (1937); Pupillary Block (2026); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Weight: unk, ethnicity: unk, race: unk.(b)(4).Lens work order search-no similar complaint type events reported for units within the same lot.Claim# (b)(4).
Event or Problem Description
The reporter indicated the surgeon implanted 13.2mm tmicl13.2 implantable collamer lens, -7.5/+2.0/170 (sphere/cylinder/axis) into the patients left eye (os) on (b)(6) 2021.The surgeon reports pupil block, elevated iop, 2+ corneal edema, and shallow anterior chamber.Also reported is an enlargement of the pi-yag and administration of combigan, pilocarpine, topical iop-reducing drops, and diamox.Reportedly, vision and iop both returned to normal and pupillary block is considered resolved.The problem is resolved.
Additional Manufacturer Narrative
B5-additional information: per update, reported iop is currently 25mmhg despite being on combigan and lumigan.3+ pigment in the angle and pigment more prominently visible inferior.Rhopressa recommended.Reportedly increased pigment is likely due to repeat yag pi and will most likely resolve over time.H6-clinical code 4581 (3+ pigment in the angle, more prominently visible inferior).Claim# (b)(4).
Additional Manufacturer Narrative
B5: updated information: reportedly the elevated iop was resolved on (b)(6) 2021.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
• 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: 12558571
• Report Number: 2023826-2021-03803
• Device Sequence Number: 19078391
• Product Code: QCB
• UDI-Device Identifier: 00841542108683
• UDI-Public: 00841542108683
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/09/2021

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: 07/31/2023
• Device Model Number: TMICL13.2
• 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: 09/09/2021
• Supplement Date Received by Manufacturer: 10/12/2021; 11/18/2021
• Initial Report FDA Received Date: 09/30/2021
• Supplement Report FDA Received Date: 10/22/2021; 12/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 37 YR
• Patient Sex: Female