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

Model Number PCB00

Device Problems Break (1069); Crack (1135)

Patient Problem No Patient Involvement (2645)

Event Date 01/06/2021

Event Type  malfunction  

Manufacturer Narrative

If implanted, give date: not applicable, as lens was not implanted.If explanted, give date: not applicable, as lens was not implanted.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that the inserter of the preloaded device bent over the intraocular lens (iol) instead of pushing it out.There was no patient contact.The event was observed when inserting into the eye.No further information is available.

Manufacturer Narrative

Correction and additional information: section b5: additional: subsequent follow up information received from the surgery center confirms that the issue inserter bent over the lens was associated with a different serial number (sn(b)(6) and the actual issue associated with the serial number captured in the report medwatch 2648035-2021-07315 was torn cartridge.There was no patient contact.Section h6: additional: medical device problem code: 1135 - crack upon reviewing the complaint folder, it has been determined that the original issue with the preloaded intraocular lens (iol) was torn cartridge and the issue occurred prior to any patient contact.Based on our reportable criteria, this report is no longer a reportable event.Therefore, an emdr is required to state that no further follow ups will be sent out under medwatch 2648035-2021-07315.G8: correction: in review of medwatch 2648035-2021-07315 and per new information received, this event has been assessed not reportable.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: 11378708
• MDR Text Key: 234565572
• Report Number: 2648035-2021-07315
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474558489
• UDI-Public: (01)05050474558489(17)221218
• Combination Product (y/n): N
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 04/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/18/2022
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000310
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1