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

Lot Number	SB04327
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/10/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Lenstec can confirm that all procedures in the manufacturing and packaging of the lens were conducted correctly.Due to the absence of the lens, lenstec was unable to perform a more thorough investigation of the complaint.We are therefore unable to determine a specific cause for the torn lens.Lenstec believes that the lens, its design and the manufacturing process are not at fault due to the extensive testing that we have performed on this model.Additionally, lenstec is unable to comment on the suitability of the monarch iii 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 that "during insertion dr.Noticed lens became torn in two places.The incision was enlarged to remove the lens.A different lens was implanted, stitch used, edema noted, waiting to resolve on its own".

• Brand Name: SOFTEC I
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): LENSTEC BARBADOS INC.; airport commercial centre; pilgrim road; christ church, ; BB
• MDR Report Key: 8582946
• Report Number: 9613160-2019-00017
• Device Sequence Number: 3236727
• Product Code: HQL
• UDI-Device Identifier: 00844369029704
• UDI-Public: 00844369029704
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P090022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/06/2019

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: 08/09/2023
• Device Lot Number: SB04327
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/10/2019
• Initial Report FDA Received Date: 05/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1