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

Lot Number	SB18217
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Inflammation (1932); Visual Impairment (2138); Eye Pain (4467)
Date of Event	06/05/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There is no evidence to suggest that any aspect of the device was responsible for the reported event.Additional information is being sought and assessment by the medical monitor is ongoing, once completed a supplemental report will be submitted.
Event or Problem Description
Lenstec received an email staing "visual acuity decline, pupillary exudation".
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 previous complaints from these batches.The lenses that were returned for testing were intact and no defects were noted.The saline solution was free of particles.Additionally, lenstec is unable to comment on the compatibility of the injector reported as used for the surgery amongst other surgical instruments or the sterility processes used by the facility.Furthermore, lenstec's medical monitor stated that there was no indication that anything was abnormal with any of these implants.There was no evidence to suggest that any aspect of these devices was responsible for the reported incident.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 this model.
Event or Problem Description
Lenstec received an email stating "visual acuity decline, pupillary exudation".

• Brand Name: SOFTEC I
• 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: 19737088
• Report Number: 9613160-2024-00049
• Device Sequence Number: 20609954
• Product Code: HQL
• UDI-Device Identifier: 00844369029483
• UDI-Public: 00844369029483
• 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: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2024

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: SB18217
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/13/2024
• Supplement Date Received by Manufacturer: 06/13/2024
• Initial Report FDA Received Date: 07/13/2024
• Supplement Report FDA Received Date: 09/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/12/2024
• 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