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

Model Number	MICL 12.6
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Intraocular Pressure Increased (1937); No Code Available (3191)
Date of Event	12/17/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Weight: unk.Ethnicity: unk.Race: unk.(b)(4).
Event or Problem Description
The reporter indicated that a 12.6mm, micl12.6, -16.0 diopter, implantable collamer lens was implanted into the patient's left eye (os) on (b)(6) 2019.The lens was removed on (b)(6) 2019 "due to eye pressure too high." no replacement lens implanted.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: h3- device evaluation: lens was returned in liquid in a specimen cup.Visual inspection found the haptic torn.Claim# : (b)(4).
Additional Manufacturer Narrative
Additional information: b5- the reporter indicated the a12.6mm micl 12.6 of -16.0 diopter implantable collamer lens was implanted into the patients left eye (os) on (b)(6) 2019.The lens was removed on (b)(6) 2019 due to pressure spike secondary to high vault.Narrow angles, pigment and blood in the angles.Patients is now back to normal.Doctor is planning on placing a smaller icl.No additional information has been provided at this time.Corrected data: device available for evaluation date in previous mdr should be corrected to (b)(6) 2020.Claim# (b)(4).
Additional Manufacturer Narrative
Corrected data: g3- date in previous mdr is corrected to (b)(6) 2020.Device code- 1583 should be included in 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: 9689153
• Report Number: 2023826-2020-00281
• Device Sequence Number: 355547
• Product Code: MTA
• UDI-Device Identifier: 00841542103145
• UDI-Public: 00841542103145
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/22/2020

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 12.6
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2020
• Initial Date Received by Manufacturer: 01/22/2020
• Supplement Date Received by Manufacturer: 05/05/2020; 11/23/2020; 05/17/2021
• Initial Report FDA Received Date: 02/10/2020
• Supplement Report FDA Received Date: 06/25/2020; 05/14/2021; 05/17/2021
• 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; FOAMTIPPLUNGER MODEL#FTP,LOT#UNK; INJECTOR MODEL#MSI-PF,LOT#UNK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 34 YR