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

Model Number	MICL 13.2
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Adverse Event Without Identified Device or Use Problem (2993); Unintended Movement (3026)
Health Effect - Clinical Codes	Intraocular Pressure Increased (1937); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age or date of birth: unk.Sex: unk.Weight: unk.Ethnicity: unk.Race: unk.Date of birth: unk.Implant date: unk.Explant date: unk.Device evaluation: lens was returned in liquid, in lens case vial.Visual inspection found a tear on a haptic.Work order search: no similar complaint type events were reported for units within the same lot.Claim # (b)(4).
Event or Problem Description
A damaged (tear on haptic) 13.2mm, micl 13.2, -10.5 diopter, implantable collamer lens was returned to staar." os (tanya moore ) replaced old with new icl", was handwritten on the lens packaging box.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
Claim# (b)(4).
Event or Problem Description
The reporter indicated that a 13.2mm, micl13.2, -10.5 diopter, implantable collamer lens was implanted into the patients left eye (os) on (b)(6) 2012.On (b)(6) 2019 the lens was exchanged for the same model lens, length and diopter due to low vault overtime, significant reduction of irido-corneal angles, partial angle closure (focal angle closure) and progressive narrowing of angle with elevated iop (that required medical intervention).This exchange resolved the problem.The cause of this event was due to the lens being implanted upside down.The reporter stated " the original icl was inadvertently inverted on insertion.This was not recognized until several years after surgery, since the patient had good vision and was temporarily lost to follow up.She was referred back to me internally from a colleague who noted focal angle closure in one eye only and increasing iop.Ubm revealed an inverted icl in that eye, which i exchanged successfully.I believe that the smaller incision butterfly style injector i was using at the time for several months (on advice of the local rep at that time) contributed to the inversion of the icl.".
Additional Manufacturer Narrative
H6- patient code 3191: significant reduction of ica, partial angle closure (focal angle closure), narrowing of angle, secondary medical (meds) and surgical (exchange) intervention.H6- work order search: a work order search was performed for the correct serial number and no similar complaint type events were reported for units within the same lot.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: 9648851
• Report Number: 2023826-2020-00206
• Device Sequence Number: 2767882
• Product Code: MTA
• UDI-Device Identifier: 00841542103305
• UDI-Public: 00841542103305
• 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: 2012
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/30/2020

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: 01/31/2014
• Device Model Number: MICL 13.2
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2019
• Initial Date Received by Manufacturer: 01/03/2020
• Supplement Date Received by Manufacturer: 01/31/2020; 05/13/2020
• Initial Report FDA Received Date: 01/30/2020
• Supplement Report FDA Received Date: 03/03/2020; 05/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention