MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. SMARTLOAD TECNIS 1-PIECE; MONOFOCAL IOLS

Model Number GCB00

Device Problem Difficult to Insert (1316)

Patient Problems Pain (1994); No Code Available (3191)

Event Date 09/24/2020

Event Type  Injury  

Manufacturer Narrative

Age/date of birth: unknown/ not provided.Sex/gender: unknown/ not provided.Serial#: unknown/not provided catalogue#: a complete catalogue # is unknown, as product serial number was not provided.Expiration date: unknown as product serial number was not provided.Udi #: unknown as product serial number was not provided.If implanted; give date: lens was not implanted.If explanted; give date: lens was not implanted, therefore not explanted.(b)(6).Device manufacture date: unknown as product serial number was not provided.(b)(4).Attempts have been made to obtain missing information; however, to date, no response has been received.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that the surgeon had difficulty to implant the lens even after they enlarged the incision.The patient complained that it hurt and surgeon used a new lens, non-johnson & johnson model, was implanted instead without any further complication reported.No additional information was provided.

Manufacturer Narrative

Section d10 - device available for evaluation? yes.Section d10 - returned to manufacturer on: 11/18/2020.Section h3 - device returned to manufacturer? yes.Device evaluation: visual inspection using magnification was performed to the returned unit.Residues of viscoelastic material was observed on the cartridge.No damaged was observed to the cartridge and the lens was found stuck and exposed at the cartridge tip section.The smartload assembly was verified and no manufacturing defects were observed that could impair functionality in the device.The condition in which the sample was returned was consistent with a product that was handled and prepared for a surgical process.Based on the sample evaluation, there is no evidence to suggest that the complaint unit has been affected by the manufacturing process.The complaint issue reported was verified.However, it is not possible to confirm if the conditions observed on device are related to manufacturing, as the reported device was previously handled.Based on the analyzed of the returned; there is no indication of a product malfunction and quality deficiency.Manufacturing record evaluation: the manufacturing records for the intraocular lens could not be reviewed as no serial number was provided.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

• Brand Name: SMARTLOAD TECNIS 1-PIECE
• Type of Device: MONOFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 10702785
• MDR Text Key: 212099597
• Report Number: 2648035-2020-00766
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Public: (01)
• Combination Product (y/n): Y
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/17/2020

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?: Yes
• Device Operator: Health Professional
• Device Model Number: GCB00
• Device Catalogue Number: GCB000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2020
• Initial Date Manufacturer Received: 09/24/2020
• Initial Date FDA Received: 10/20/2020
• Supplement Dates Manufacturer Received: 12/04/2020
• Supplement Dates FDA Received: 12/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention