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

Model Number	TMICL13.7
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes	Intraocular Pressure Increased (1937); No Code Available (3191)
Date of Event	03/14/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lens was returned in liquid, in a specimen cup.Visual inspection found no visible damage to the lens.(b)(4).No similar complaint was reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter indicated the surgeon implanted a 13.7mm tmicl13.7 implantable collamer lens, - 6.0/+4.0/096 (sphere/cylinder/axis), in the patient's right eye (od) on (b)(6) 2019.The lens was explanted on (b)(6) 2019 due to pupil block, with elevated intraocular pressure (iop), angle closure and significant reduction of irido-corneal angles.Prior to explant, gave the patient diamox, topical ocular antihypertensive medications, then iv mannitol attempting to lower iop, then attempted tapped anterior chamber at slit lamp attempting to lower iop.These measures were unsuccessful and iop continued to rise.Gonioscopy demonstrated angle closure, and the decision was made to explant.The surgeon plans to implant another icl lens.The cause of the event was due to oversized lens.The patient condition at one day post-op, mild corneal edema and angle open.

• 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: 8511516
• Report Number: 2023826-2019-00597
• Device Sequence Number: 1921391
• Product Code: QCB
• UDI-Device Identifier: 00841542110686
• UDI-Public: 00841542110686
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/15/2019

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: 01/31/2021
• Device Model Number: TMICL13.7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2019
• Initial Report FDA Received Date: 04/12/2019
• 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: Required Intervention
• Patient Age: 27 YR