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

Model Number 1MTEC30

Device Problem Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/14/2020

Event Type  malfunction  

Manufacturer Narrative

If implanted; give date: n/a.The cartridge is not an implantable device.If explanted; give date: n/a.The cartridge is not an implantable device; therefore, not explanted.Phone: (b)(6).Pma/510(k) number: unknown as product lot number was not provided.Device manufacture date: unknown as product lot number was not provided.Attempts have been made to obtain missing information.However, to date, no further details could be provided.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that a piece of the intraocular lens (iol) cartridge has torn off and now is located in the sulcus.The surgeon tried to remove the piece but unfortunately failed.The doctor was put in touch with our medical advisor and was advised to remove the piece.Doctor has told us that he is going to follow up with the patient and try to remove the piece later.Material is not available (discarded) and so far no adverse effects on the patient have been reported.Through follow-up we learned that the piece remains in the eye and that the issue occurred on the (b)(6) 2020.

Manufacturer Narrative

Corrected data: in review of section e in follow-up 1, the country was inadvertently selected as united states, however, the country should have been netherlands.All pertinent information available to johnson & johnson surgical vision, inc has been submitted.

Manufacturer Narrative

Additional information: section b5 - describe event or problem: the cartridge was discarded while the particle remains in the ye pending further post-operative checks.The cartridge model was identified as a 1mtec30.No additional information was provided.Section d1 - brand name: platinum 1 series.Section d4 - model #: 1mtec30.Section d4 - catalogue#:1mtec30.Section g4 - pma/510(k) #: k081545.Device evaluation: no material was returned for evaluation as it was either discarded or remains implanted in the patients eye.Therefore, a failure analysis of the complaint device could not be performed.Manufacturing record evaluation: the manufacturing records for the cartridge could not be reviewed as the lot number could not be 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: CARTRIDGE
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• MDR Report Key: 11151922
• MDR Text Key: 240453712
• Report Number: 2648035-2021-07034
• 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,Followup
• Report Date: 03/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2021
• 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: 03/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1