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

Model Number	TMICL12.6
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Weight: unk, race: unk, ethnicity: unk.Work order search: no similar complaint was reported for units within the same lot.Claim # (b)(4).
Event or Problem Description
The reporter indicated the surgeon inserted and removed a 12.6mm tmicl12.6 implantable collamer lens, -09.00/+3.0/087 (sphere/cylinder/axis), within the same surgery due to the lens was inserted upside down in the patients left eye (os).There was no patient injury.The reporter indicated the lens appeared normal upon loading but the haptics and lens were not as flexible and difficult to move.The surgeon could not visualize the markings on the haptics to ensure appropriate placement and therefore could not be sure the lens was not flipped.The lens was replaced within the same surgery with a longer lens and the problem was resolved.Post-op, vision was only hm and there was significant corneal clouding.See mfr.Report # 2023826-2021-02790 for replacement lens.The lens was discarded.Additional information has been requested but none has been forthcoming.
Additional Manufacturer Narrative
H6: 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
B5 - the reporter indicated the surgeon implanted a 12.6mm tmicl12.6 implantable collamer lens -09.00/+3.0/087 (sphere/cylinder/axis) upside down into the patients left eye (os) on (b)(6) 2022.There was no patient injury.The lens was intraoperatively implanted; removed and replaced with another 12.6mm lens.This resolved the problem.Post-op vision was only hm and there was significant corneal clouding.(b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Common Device Name: PHAKIC TORIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer (Section G): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: cynthia thai ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 12200488
• Report Number: 2023826-2021-02534
• Device Sequence Number: 4136462
• Product Code: QCB
• UDI-Device Identifier: 00841542106740
• UDI-Public: 00841542106740
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: TMICL12.6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 06/23/2021
• Supplement Date Received by Manufacturer: 08/27/2021; 01/31/2022
• Initial Report FDA Received Date: 07/20/2021
• Supplement Report FDA Received Date: 09/26/2021; 01/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/11/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• 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 AND LOT # UNK.
• Patient Age: 31 YR
• Patient Sex: Female