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

Lot Number	F220309
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Uveitis (2122)
Type of Reportable Event	Serious Injury
Event or Problem Description
Lenstec received an email " secondary uveitis after implantation of lenstec iol".
Additional Manufacturer Narrative
Based on the review of the batch documentation, lenstec can confirm that all procedures in the manufacturing and packaging of the devices were conducted correctly.The endotoxin results were within acceptable limits and we have not received any other complaints from these batches.Additionally, the assessment by lenstec's medical monitor stated that it is highly unlikely that this incident was lens related.There was no evidence to suggest that any aspect of these devices was responsible for the reported event after implantation.Furthermore, lenstec confirms that the lenses, their design and the manufacturing process are not at fault due to the extensive testing that we have performed on these models.Lenstec is currently awaiting information from the hospital regarding the event and if any investigation has been conducted.As such, we will provide a supplemental report on completion of our investigations.
Additional Manufacturer Narrative
This supplemental report includes the response received from the distributor stating that the previous cases have been completely cured and there were no sequelae after active treatment in the hospital.No further information regarding these incidents is available.No information was provided on whether a tass investigation would be conducted at the hospital level, however, it was noted by the distributor that literature was reviewed to determine if another factor could be the cause of these incidents.Lenstec is conducting further testing based on the literature provided by the distributor and will provide a final report on completion of our investigation.Based on the review of the batch documentation, lenstec can confirm that all procedures in the manufacturing and packaging of the devices were conducted correctly.The endotoxin results were within acceptable limits and we have not received any other complaints from these batches.Additionally, the assessment by lenstec's medical monitor stated that it is highly unlikely that this incident was lens related.There was no evidence to suggest that any aspect of these devices was responsible for the reported issue after implantation.Furthermore, lenstec confirms that the lenses, their design and the manufacturing process are not at fault due to the extensive testing that we have performed on these models.
Event or Problem Description
Lenstec received an email " secondary uveitis after implantation of lenstec iol".
Additional Manufacturer Narrative
Based on the investigation previously conducted, lenstec confirms that all procedures in the manufacturing and packaging of the devices were conducted correctly.The endotoxin results were within acceptable limits and we have not received any other complaints from these batches.Additionally, the assessment by lenstec's medical monitor stated that it is highly unlikely that these incidents were lens related.Furthermore, the testing results confirmed the absence of detectable levels of aluminium.There was no evidence to suggest that any aspects of these devices were responsible for the reported uveitis after implantation.Lenstec confirms that the lenses, their design and the manufacturing process are not at fault due to the extensive testing that we have performed on these models.
Event or Problem Description
Lenstec received an email "secondary uveitis after implantation of lenstec iol.".

• Brand Name: SOFTEC HD
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): LENSTEC BARBADOS INC.; airport commercial centre; pilgrim road; christ church, ; BB
• Manufacturer (Section G): LENSTEC BARBADOS INC.; airport commercial centre; pilgrim road; christ church, ; BB
• Manufacturer Contact: jimmy chacko ; 1765 commerce ave. n.; st. petersburg, FL 33716 ; 7275712272
• MDR Report Key: 17504687
• Report Number: 9613160-2023-00011
• Device Sequence Number: 14989933
• Product Code: HQL
• UDI-Device Identifier: 00844369027236
• UDI-Public: 00844369027236
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P090022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/05/2024

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 Lot Number: F220309
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 07/11/2023; 07/11/2023
• Initial Report FDA Received Date: 08/10/2023
• Supplement Report FDA Received Date: 09/15/2023; 01/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2022
• 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
• Patient Sex: Unknown