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

Model Number	MICL12.6
Medical Device Problem Codes	Off-Label Use (1494); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Dry Eye(s) (1814); Intraocular Pressure Increased (1937); Pain (1994); No Code Available (3191)
Date of Event	02/06/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Report number - mw5093020.(b)(4).Work order search: no 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, - 11.0 diopter, in the patients left eye (os), on (b)(6) 2019.The patient reported eye pain, which was not resolved with artificial tears or warm compresses.The patient got a second opinion but was unable to solve the source of the pain.The patient requested the lens be removed and the lens was explanted on (b)(6) 2020.There are no plans to implant another icl lens.The cause of the event was unknown.The patient reported post-op, her eye pressure had increased and was treated with combigan.Was also treated for dry eye for over a month.The patient's current condition is still has occasional pain, especially at night.
Additional Manufacturer Narrative
Additional information: h3- device evaluation: lens was returned in liquid in a lens case/vial in a ziploc bag.Visual inspection found no visible damage to the lens.H6- device history review: the device has been manufactured within established process parameters.Claim# (b)(4).
Additional Manufacturer Narrative
Additional information: h6- patient code 1937 should be removed from initial mdr as it is not applicable.B5- it is also noted that prior to surgery, in (b)(6) of 2019 she had a "hair clip injury" in the right eye that resulted in a bruised eyelid.The doctor found no evidence of an injury to the eye itself.Patient went to several other doctors for opinions and was at some point placed on combigan to treat elevated pressure related to steroid drop use.Combigan was noted to have been first used on (b)(6) 2020 in the right eye only.Combigan was used in both eyes until (b)(6) 2020, and was discontinued on (b)(6) 2020 and then again resumed on (b)(6) 2020 which reported the patient had 34mmhg eye pressure in the left eye.The day before they found her eye pressure to be 23mmhg.Patient continued using combigan as of (b)(6) 2020 and has been to a corneal specialist who is investigating the possibility of ophthalmic neuralgia.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
• MDR Report Key: 9772179
• Report Number: 2023826-2020-00375
• Device Sequence Number: 16932304
• Product Code: MTA
• UDI-Device Identifier: 00841542103046
• UDI-Public: 00841542103046
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/10/2020

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: 12/31/2020
• Device Model Number: MICL12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2020
• Initial Date Received by Manufacturer: 02/10/2020
• Supplement Date Received by Manufacturer: 03/27/2020; 07/09/2020
• Initial Report FDA Received Date: 02/28/2020
• Supplement Report FDA Received Date: 04/23/2020; 07/10/2020
• 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 SFC-45 - LOT # UNK; FOAM TIP PLUNGER MODEL FTP - LOT # UNK; INJECTOR MODEL MSI-PF - LOT # UNK; CARTRIDGE MODEL SFC-45 - LOT # UNK; FOAM TIP PLUNGER MODEL FTP - LOT # UNK; INJECTOR MODEL MSI-PF - LOT # UNK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR