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

Model Number	TMICL12.1
Medical Device Problem Codes	Misfocusing (1401); Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes	Intraocular Pressure Increased (1937); Blurred Vision (2137); No Code Available (3191)
Date of Event	06/27/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Work order search: no similar complaint type events were reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter indicated that a 12.1mm, tmicl 12.1, intraocular lens was implanted into the patients eye on (b)(6) 2019 was removed on (b)(6) 2019 due to excessive vault, pupil block with elevated iop and angle closure.At patients last visit ((b)(6) 2019) status of the eye was reported as dilated and a/c cells.On (b)(6) 2019 it was reported that the explant resolved the issues and patient is still recovering.
Additional Manufacturer Narrative
Device evaluation: the lens was returned in liquid in a specimen cup.Visual inspection found no visible damage to the lens.Patient code 3191: unreactive (fixed) pupil, pigment dispersion.Date of event: corrected to (b)(6) 2019 in initial mdr.The reporter indicated that a 12.1mm tmicl12.1 intraocular lens was implanted into the patient's right eye (od) on (b)(6) 2019.The lens was explanted on (b)(6) 2019 due to excessive vault, pupil block, elevated iop, angle closure, pigment dispersion, unreactive (fixed) pupil, and blurred vision.It was reported that the explant resolved the issue.However, the post-op data states that the patient is still experiencing dilated pupil with a/c cells.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: 8850038
• Report Number: 2023826-2019-01367
• Device Sequence Number: 16548714
• Product Code: QCB
• UDI-Device Identifier: 00841542105149
• UDI-Public: 00841542105149
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2019

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: 05/31/2021
• Device Model Number: TMICL12.1
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2019
• Initial Date Received by Manufacturer: 07/10/2019
• Supplement Date Received by Manufacturer: 08/08/2019
• Initial Report FDA Received Date: 08/01/2019
• Supplement Report FDA Received Date: 08/26/2019
• 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: 26 YR