MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. PLATINUM 1 SERIES; SURGICAL ADJUNCTS

Model Number 1MTEC30

Device Problem Contamination (1120)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Age/date of birth: unknown/not provided.Sex/gender: unknown/not provided.Date of event: unknown, not provided.If implanted; give date: n/a (not applicable).The cartridge is not an implantable device.If explanted; give date: n/a (not applicable).The cartridge is not an implantable device; therefore, not explanted.(b)(6).All pertinent information available to johnson and johnson surgical vision has been submitted.

Event Description

It was reported that after the intraocular lens (iol) was implanted in the eye, the surgeon found tiny fragment which she pinched it out.It was indicated that the patient did not react / show any problem.The surgeon experienced the same situation twice in different hospitals with two different lenses in two weeks.The surgeon thinks the fragment is from the cartridge and not the iol as they checked the lens before loading it into the cartridge and the lens was clear from fragment.No additional information was provided.This mdr report pertains to the second reported incident.A separate report will be submitted for the first incident.

Manufacturer Narrative

This correction mdr is being submitted to address inaccurate information in section f on the xml version of the previous submission caused by a software glitch in the transmission process.The internal non-conformance numbers for this software issue are nr-0148919 and capa-010215.

Manufacturer Narrative

In follow up, it was clarified that the serial number (b)(6) entered in section ''d11'' of the initial mdr report was incorrect.The correct serial number (sn) for the concomitant product was reported to be "(b)(6)" which is captured in this supplemental mdr report.The following field was updated accordingly: section d11: concomitant medical product: intraocular lens sn: (b)(6).Device evaluation: the cartridge was not returned for evaluation.The customer provided photos that show the alleged foreign material or fragment as described by the customer; however, no photos of the cartridge was provided.Based on the provided photos, it could not be determined that the foreign material is or not related to the cartridge.Manufacturing records review: the manufacturing records for the device were reviewed and no discrepancy found during the mrr (manufacturing record review).The units was manufactured and released according to specifications.A search in complaint system revealed no additional complaint has been received for this production order number.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.H3 other text : placeholder.

Manufacturer Narrative

Additional information: the original lens case was received with the ¿tiny fragment¿ described as a ¿silk-like substance¿.The complaint event was confirmed, however since the lens case was opened and handled by the customer, how and when this foreign material was introduced cannot be confirmed.The foreign material was sent to an external lab for evaluation.A summary of the results is as follows: ftir analysis indicates the material is consistent with polypropylene by comparison with a reference from the external laboratories spectrum library.Specifically, the peaks at ~2951, 2917, 2871, 2837, 1455, 1375, 1167, 997, 972, 899, 840 and 809 cm-1 overlap with the polypropylene reference, supporting the proposed assignment.In addition, the broad peaks at ~3349 and 1645 cm-1 indicate the presence of -oh bonding which usually suggests water content.The results of the external investigation were then reviewed by the manufacturing site subject matter expert and the following information was provided: based on the evaluation performed, the coated cartridge is the potential source of the foreign material.Investigation request was opened for the 1mtec30 cartridge, but the used cartridge sample was not returned for evaluation; however, the manufacturing process record was evaluated and the devices were manufactured and released within specifications.Although the foreign material has a correlation with the coated cartridge (cartridge, molded, platinum 1 series) we cannot confirm if the foreign material came from the cartridge because the cartridge sample was not returned for evaluation.The coated cartridge manufacturing process has controls to identify and discard units with ¿foreign material¿.Based on the manufacturing controls in-place, manufacturing process record review and the evaluation of the foreign material, the reported complaint cannot be confirmed as cartridge manufacturing process related.All pertinent information available to johnson and johnson surgical vision has been submitted.

• Brand Name: PLATINUM 1 SERIES
• Type of Device: SURGICAL ADJUNCTS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 9909219
• MDR Text Key: 185905869
• Report Number: 2648035-2020-00307
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 05050474540323
• UDI-Public: (01)05050474540323(17)200708(10)CE06409
• Combination Product (y/n): Y
• 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,Followup
• Report Date: 01/01/2005,10/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/08/2020
• Device Model Number: 1MTEC30
• Device Catalogue Number: 1MTEC30
• Device Lot Number: CE06409
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 10/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: INTRAOCULAR LENS (B)(6).; MODEL ZXR00 LENS (B)(6).; MODEL ZXR00 LENS SN: (B)(4)