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

Model Number	MICL 13.2
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Intraocular Pressure Increased (1937); No Code Available (3191)
Date of Event	05/20/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).No similar complaint type events were reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter indicated that 13.2mm, micl13.2, -15.0 diopter, implantable collamer lens was implanted on (b)(6) 2019 and explanted on (b)(6) 2019 due to elevated pressure that could not be resolved with additional pi's and meds.Additional information has been requested but none has been forthcoming.If additional information is received a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
Additional information: event: the reporter indicated that 13.2mm, micl13.2, -15.0 diopter, implantable collamer lens was implanted into the patients right eye (od) on 05 mar 2019.On 21 may 2019 the lens was explanted due to angle closure with elevated iop that could not be resolved with additional pi and medication.The reporter stated "increased iop d/t either angle closure from anteriorly rotated ciliary body vs atypical aqueous misdirection." status of the eye: doing well after icl removal.It was reported that the angles are open.Iop is normal.No loss of best corrected vision but patient is back to wearing glasses.Patient code 3191: angle closure.Claim # (b)(4).
Additional Manufacturer Narrative
Corrected data: b3- "05/20/2019" should be in the previous mdr.D11- "injector model: msipf - inj lot: 1449232; cartridge model: sfc45 - cart lot: 1446792; inj system model: ftp - inj system lot: 1448653" should be in the previous mdr.Claim# (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Common Device Name: PHAKIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 9153161
• Report Number: 2023826-2019-01857
• Device Sequence Number: 16788307
• Product Code: MTA
• UDI-Device Identifier: 00841542103398
• UDI-Public: 00841542103398
• Combination Product (Y/N): N
• 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: other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/04/2019

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: 10/31/2020
• Device Model Number: MICL 13.2
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/04/2019
• Supplement Date Received by Manufacturer: 11/08/2019; 03/06/2020
• Initial Report FDA Received Date: 10/03/2019
• Supplement Report FDA Received Date: 12/06/2019; 03/06/2020
• 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: SFC45, LOT #: 1446792.; INJ SYSTEM MODEL: FTP, LOT #: 1448653.; INJECTOR MODEL: MSIPF, LOT #: 1449232.; UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 35 YR