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

Model Number	MICL13.2
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Codes	Intraocular Pressure Increased (1937); Pupillary Block (2026); Blurred Vision (2137); No Code Available (3191)
Date of Event	12/12/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluation: product evaluation found that the lens was returned dry with clear surgical residue/debris in a small pouch taped to paper with facility information.Visual inspection found the lens returned in pieces being unable to evaluate.(b)(4).Work order search: no similar complaint type events were reported for units within the same lot.Claim #(b)(4).
Event or Problem Description
The reporter indicated that the surgeon implanted a 13.2 mm micl13.2, -9.5 diopter, implantable collamer lens in the patient's eye on (b)(6) 2017.On (b)(6) 2017, the lens was explanted due to spiked iop.Attempts to obtain additional information have been unsuccessful.
Additional Manufacturer Narrative
Patient's name is corrected to (b)(6).The reporter indicated that the surgeon implanted a 13.2mm micl13.2 implantable collamer lens of -9.5 diopter in the patient's right (od) eye on (b)(6) 2017.On (b)(6) 2017, the lens was explanted due to excessive vaulting, elevated iop (pupillary block), narrowing of angles, shallowing of acd and angle closure.There was no patient injury.The patient currently has blurred vision, an enlarged/ unresponsive pupil (urrets-zavalia syndrome) and photophobia.The reporter stated that the doctor might suggest soft contacts to be used by patient in order to improve the patient condition.(b)(4).Conclusion code: as per the dfu, this lens is contraindicated for implantation in patients above the age of 45 years and in those with acd (anterior chamber depth) less than 3.0mm corrected data: device evaluation: the lens was returned dry with clear surgical residue/ debris on the product, in a small pouch taped to a paper with facility information.Visual inspection found the lens returned in pieces and presence of residue on the lens.(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: 7187682
• Report Number: 2023826-2018-00043
• Device Sequence Number: 63295
• Product Code: MTA
• UDI-Device Identifier: 00841542103282
• UDI-Public: 00841542103282
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2017

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: Physician
• Device Expiration Date: 07/31/2019
• Device Model Number: MICL13.2
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/15/2017
• Supplement Date Received by Manufacturer: 01/17/2018
• Initial Report FDA Received Date: 01/12/2018
• Supplement Report FDA Received Date: 01/24/2018
• 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
• Patient Age: 53 YR