MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. TECNIS IOL; INTRAOCULAR LENS

Model Number PCB00

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Not applicable.There was no patient contact reported.Date of event: date unknown/ not provided.If implanted; give date: not applicable, there was no patient contact, lens was not implanted.If explanted; give date: not applicable, there was no patient contact, lens was not implanted, therefore not explanted.(b)(6).All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

Event Description

It was reported there was an issue with pcb00 intraocular lens.Customer mentioned that the lens was defective, no more information is available.No contact with the patients eye, no patient involvement.Issue first identified upon opening of the packaging.No additional information was provided.

Manufacturer Narrative

Section d9 - device availability :yes.Section d9 - returned to manufacturer ticked.Section h3 - device evaluated by manufacturer yes.Device evaluation: visual inspection using magnification was performed to the returned sample.The plunger and pushrod was observed in advanced position.The pushrod was observed that overrides the lens in the cartridge.Residues of lubricating material were observed on cartridge.The cartridge tip was observed deformed.The lens was observed stuck at the cartridge tip section.It was too hard to remove the lens from the cartridge to address the condition reported.Based on the sample evaluation, there is no evidence to suggest that the complaint unit has been affected by the manufacturing process.The condition in which the sample returned is consistent with a product that was handled and prepared for a surgical process.The complaint issue reported could not be verified.Based on the analysis of the returned, there is no indication of product quality deficiency.Manufacturing record review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured according to specifications.The search revealed that no similar complaint for this production order number has been received.Conclusion: as a result of the investigation there is no indication of a product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS IOL
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• MDR Report Key: 11175721
• MDR Text Key: 242007567
• Report Number: 2648035-2021-07076
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474558298
• UDI-Public: (01)05050474558298(17)230929
• Combination Product (y/n): N
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 03/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/29/2023
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/16/2020
• Initial Date FDA Received: 01/14/2021
• Supplement Dates Manufacturer Received: 02/10/2021
• Supplement Dates FDA Received: 03/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1