MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. PLATINUM 1 SERIES; SURGICAL ADJUNCTS

Model Number 1MTEC30

Device Problem Contamination (1120)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/11/2020

Event Type  malfunction  

Manufacturer Narrative

Patient info: information unknown/ not provided.Lot#: unknown/not provided expiration date: unknown as product lot number was not provided.Udi #: unknown as product lot number was not provided.Phone: (b)(6).Manufacture date: unknown as product lot number was not provided.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that during implantation a particle of plastic was found with the iol in the eye.The particle was removed and kept for investigation.The customer thinks that it is a piece of the cartridge of the iol.No patient injury or other interventions.Through follow-up we learned the customer thinks it is from the lens but are not sure.No additional information was provided.

Manufacturer Narrative

Device evaluation: the material has not yet been returned for evaluation.Therefore, a failure analysis of the complaint device could not be performed.Manufacturing record evaluation: the manufacturing records for the intraocular lens could not be reviewed since no lot details were 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: PLATINUM 1 SERIES
• Type of Device: SURGICAL ADJUNCTS
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• MDR Report Key: 11167255
• MDR Text Key: 234324793
• Report Number: 2648035-2021-07088
• Device Sequence Number: 1
• Product Code: KYB
• Combination Product (y/n): N
• PMA/PMN Number: K081545
• 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: 03/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1MTEC30
• Device Catalogue Number: 1MTEC30
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ICB00 LENS, SN# (B)(4).