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

Model Number	MICL12.6
Medical Device Problem Codes	Misfocusing (1401); Inadequacy of Device Shape and/or Size (1583); Optical Problem (3001)
Health Effect - Clinical Codes	Cataract (1766); Intraocular Pressure Increased (1937); Iritis (1940); Blurred Vision (2137); Visual Disturbances (2140); Halo (2227); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/21/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Work order search: another similar complaint was reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter indicated the surgeon implanted a 12.6mm micl12.6 implantable collamer lens, -12.50 diopter, in the patients left eye (os) on (b)(6) 2020.The lens was explanted on (b)(6) 2020 due to intraocular pressure spike (not controllable with drops) and lens was too large, which was causing the lens to bow towards the iris, increasing the pressure.There is no lens in the eye currently, surgeon will proceed with cataract extraction as anterior changes to the natural lens occurred after explantation.Additional information has been requested but none has been forthcoming.If additional information is received, a supplemental medwatch will be submitted.
Additional Manufacturer Narrative
H3: device evaluation: the lens was returned dry, in a contact case.Visual inspection found one haptic torn.Claim # (b)(4).
Additional Manufacturer Narrative
B5 - "lens was too large" ammended to "lens was too small" in initial mdr.Claim# (b)(4).
Additional Manufacturer Narrative
Corrected data: h6 - health effect clinical code 4581: no code available (bowing of iris) should be included in initial mdr.H6 - health effect impact code 4625: additional surgery (phacoemulsification, iol implantation) should be included in initial mdr.Additional information: b5 - transient loss of bcva, glare/haloes, iritis, icl-lens contact, and icl-iris contact were also reported.The problem is reported as resolved after phacoemulsification and iol implantation.However, mild pupil corectopia is reported post explant.The cause of the event is reported as "device size may have been too small." h6 - health effect impact code 4581: no code available (icl-lens touch, icl-iris contact).(b)(4).
Additional Manufacturer Narrative
Additional information: h6- method code 3331: device history record (dhr) review: based on the results of the investigation, all released devices from the associated work orders(s), including the suspected device, have been manufactured within established parameters; and there is no indication that the manufacturing and processing of the device contributed to the complaint issue.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: 10669743
• Report Number: 2023826-2020-02328
• Device Sequence Number: 14135094
• Product Code: MTA
• UDI-Device Identifier: 00841542103077
• UDI-Public: 00841542103077
• 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: 2020
• Device Explanted Year: 2020
• 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,Followup
• Report Date (Section B): 09/16/2020

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: 12/31/2021
• Device Model Number: MICL12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2020
• Initial Date Received by Manufacturer: 09/16/2020
• Supplement Date Received by Manufacturer: 10/19/2020; 12/21/2020; 01/28/2021; 02/04/2021
• Initial Report FDA Received Date: 10/13/2020
• Supplement Report FDA Received Date: 11/03/2020; 01/27/2021; 01/28/2021; 02/09/2021
• 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#: 1429582; INJ SYSTEM MODEL: FTP, LOT# 1487145; INJECTOR MODEL: MSIPF, LOT# 1420353
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 29 YR