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

Model Number	MICL12.6
Medical Device Problem Codes	Misfocusing (1401); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); Blurred Vision (2137); No Code Available (3191)
Date of Event	01/03/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Work order search: another similar complaint was reported for units within the same lot.Claim # (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) 2018.The lens was explanted on (b)(6) 2019 due to chronic inflammation.The inflammation was treated but was unsuccessful and the lens was explanted.The patient is improving.Additional information has been requested but none has been forthcoming.If additional information is received, a supplemental medwatch will be submitted.
Additional Manufacturer Narrative
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) 2018.The lens was explanted on (b)(6) 2019 due to chronic inflammation.The patient experienced loss of best corrected visual acuity and unreactive (fixed) pupil.The anterior chamber was irrigated/evacuated of visco/fluids on (b)(6) 2019.The inflammation was treated but it was unsuccessful and the lens was explanted.There was significant resolution upon removal and the patient is improving.Device evaluation: the lens was returned dry in a specimen cup.Visual inspection found no visible damage to the lens.There was evidence of cloudy residue on the lens.Patient code: 3191 - secondary surgical intervention, anterior chamber irrigation/evacuation of visco/fluids.Patient code: 3191 - unreactive (fixed) pupil.Date of birth: (b)(6) 1990.Explanted date: (b)(6) 2019.Claim#: (b)(4).
Additional Manufacturer Narrative
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).

• 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: 8322791
• Report Number: 2023826-2019-00188
• Device Sequence Number: 2321516
• Product Code: MTA
• UDI-Device Identifier: 00841542103046
• UDI-Public: 00841542103046
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/10/2019

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: 05/31/2020
• Device Model Number: MICL12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2019
• Initial Date Received by Manufacturer: 01/10/2019
• Supplement Date Received by Manufacturer: 02/12/2019; 03/20/2019
• Initial Report FDA Received Date: 02/08/2019
• Supplement Report FDA Received Date: 03/14/2019; 04/01/2019
• 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 AND LOT NUMBER UNK; CARTRIDGE MODEL SFC-45 - LOT # UNK; FOAM TIP PLUNGER MODEL FTP - LOT # UNK; INJECTOR MODEL AND LOT NUMBER UNK; INJECTOR MODEL MSI-PF - LOT # UNK; CARTRIDGE MODEL AND LOT NUMBER UNK; INJECTOR MODEL AND LOT NUMBER UNK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 28 YR