MAUDE Adverse Event Report: STAAR SURGICAL COMPANY IMPLANTABLE COLLAMER LENS; PHAKIC TORIC INTRAOCULAR LENS

Model Number	TMICL12.6
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lens was returned in a biohazard ziploc bag wrapped in gauze and with liquid in the bag.Visual inspection found no visible damage to the lens.(b)(4).No similar complaint type events reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter states that a 12.6mm tmicl12.6 implantable collamer lens, -9.0/+3.0/072 (sphere/cylinder/axis) was explanted from the patient's left (os) eye due to it being the wrong power lens.Attempts to obtain additional information have not been successful.
Additional Manufacturer Narrative
Additional information added to previous device evaluation: dimensional and functional inspection found the lens to be within specification.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
Additional information: a1: patient id: (b)(6).A2: dob: (b)(6) 1996.D6- implant date: (b)(6) 2019.Claim# (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS
• Common Device Name: PHAKIC TORIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 9076364
• Report Number: 2023826-2019-01714
• Device Sequence Number: 2976761
• Product Code: QCB
• UDI-Device Identifier: 00841542106740
• UDI-Public: 00841542106740
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/21/2019

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: 09/30/2020
• Device Model Number: TMICL12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2019
• Initial Date Received by Manufacturer: 08/21/2019
• Supplement Date Received by Manufacturer: 09/19/2019; 04/27/2020
• Initial Report FDA Received Date: 09/17/2019
• Supplement Report FDA Received Date: 10/14/2019; 05/12/2020
• 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