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	12/06/2019
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, - 11.5 diopter, in the patients right eye (od), on (b)(6) 2019.At one-day post-op, 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 still has occasional pain.
Additional Manufacturer Narrative
H3 - device evaluation: lens was returned in a ziploc bag, in a vial with liquid and clear surgical residue on the lens.Visual inspection found no visible damage to the lens and residue on the lens.Corrected data: h6 - patient code 3191: no code available (medication: combigan) should have been included in intial medwatch report.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 order(s), including the suspected device, have been manufactured within established process parameters and there is no indication that the manufacturing and processing of the device contributed to the complaint issue.Claim#: (b)(4).
Additional Manufacturer Narrative
Corrected data: h6 - patient code: 1937 should be removed as it is not applicable.B5 - it was indicated from the reporter that prior to surgery, in (b)(6) 2019, the patient had a "hair clip injury" which resulted in a bruised eye lid.Doctor found no evidence of an injury to the eye itself.Patient received several other doctors opinions and at some point was prescribed cambigan to treat elevated iop.Combigan was noted to have been first used on (b)(6) 2020 and was discontinued on (b)(6) 2020 and then again resumed on (b)(6) 2020 which reported the patient had 13mmhg eye pressure.The day before they found her eye pressure to be 23mmhg.Patient continued to use 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: 9772182
• Report Number: 2023826-2020-00374
• Device Sequence Number: 19621372
• Product Code: MTA
• UDI-Device Identifier: 00841542103053
• UDI-Public: 00841542103053
• 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; 06/03/2020
• Initial Report FDA Received Date: 02/28/2020
• Supplement Report FDA Received Date: 04/23/2020; 06/03/2020
• 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