MAUDE Adverse Event Report: LENSTEC BARBADOS INC. SOFTEC HD; INTRAOCULAR LENS

Lot Number	171753
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Information (3190)
Date of Event	07/04/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As the lens remains implanted, a documentation review was conducted.Based on our batch documentation, lenstec can confirm that all procedures in the manufacturing and packaging of the devices were conducted correctly.Due to the absence of the lens and the requested additional information, lenstec was unable to perform a more thorough investigation of the complaint.As such, we are unable to determine a specific cause for the reported incident.Additionally, lenstec is unable to comment on the instruments used and therefore wishes to advise the user to consult the instructions for use for the correct instruments and method for implantation using the injection process to ensure successful implantation.(b)(4).].
Event or Problem Description
Lenstec received an email stating "a patient was implanted with a softec hd on (b)(6) 2018.Under the microscope, the iol surface was not found smooth and punctate.The repeated irrigation was ineffective.The iol was not removed at present.".

• Brand Name: SOFTEC HD
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): LENSTEC BARBADOS INC.; airport commercial centre; pilgrim road; christ church, BB170 92; BB BB17092
• MDR Report Key: 7744300
• Report Number: 9613160-2018-00030
• Device Sequence Number: 1365224
• Product Code: HQL
• UDI-Device Identifier: 00844369027274
• UDI-Public: 00844369027274
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P090022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/01/2018

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: 05/31/2022
• Device Lot Number: 171753
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/06/2018
• Initial Report FDA Received Date: 08/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1